TotalCare® Spo2rt® 2 Surface
Hospital Bed Surface.
95manufacturers in China registered for this device type
3catalogue numbers in this listing
5510(k) clearances naming this product code
36recalls on this code
Who Else Makes It
Concentrated in Guangdong (32), Jiangsu (20), Hebei (11). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Dunli Medical Instruments Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
| Foshan Dongfang Medical Equipment Manufactory(Ltd) | Foshan | Guangdong | Contract manufacturer | 14 |
| Genteel Homecare Products Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 12 |
| Jiangyin Newrise Medical Equipment Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 10 |
| Jiaxing Kalanchoe Medical Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 8 |
| Jiangmen Jia Mei Medical Products Co., Ltd. | Heshan | Guangdong | Contract manufacturer | 8 |
| Ningbo Hecai Medical Equipment Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 8 |
| Nantong Shunlong Physical Therapy Equipment Co., Ltd. | Rugao | Jiangsu | Contract manufacturer | 6 |
| Chengdu LI REN Electric Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 3 |
| Yuiyn HOO Industrial Limited | Dong Guan | Guangdong | Contract manufacturer | 3 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 95. All 95 manufacturers in China registered for Bed, Ac-Powered Adjustable Hospital
Record
| Listed by | Hill-ROM, Inc., United States |
|---|---|
| FDA product code | FNL |
| Device type | Bed, Ac-Powered Adjustable Hospital |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-17 |
| Record revised | 2024-05-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P1918B13 | In distribution | |
| P1918B12S | In distribution | |
| P1918B14S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drive | Drive DeVilbiss Healthcare | 190 |
| Electrical Hospital Bed | Paramount BED Co., Ltd. | 164 |
| MC Healthcare | Span-America Medical Systems, Inc. | 160 |
| NOA Medical Industries, Inc. | Hoffmann NOA Medical Industries, LLC | 99 |
| Posey | Posey Products, LLC | 95 |
| Drivemedical | Drive DeVilbiss Healthcare | 94 |
| Enterprise | Arjohuntleigh AB | 80 |
| silverfox | Silverfox Corporation Limited | 77 |
| Electrical Hospital Bed with Digital Scale | Paramount BED Co., Ltd. | 70 |
| Basic American Medical Products | GF Health Products, Inc | 66 |
| Bed, Ac-Powered Adjustable Hospital | Gendron, Inc. | 50 |
| Accessories | Joerns Healthcare | 43 |
Showing 12 of 1,249. All products under Bed, Ac-Powered Adjustable Hospital
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K962942 | 1997-02-03 |
| K922352 | 1992-10-13 |
| K915437 | 1992-06-11 |
| K864172 | 1986-11-13 |
| K864186 | 1986-11-13 |
Recalls
9 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-06-30 | Class II | Nonconforming Material/Component | Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury. | 1033 | 2022-10-20 |
| 2020-06-30 | Class II | Nonconforming Material/Component | Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury. | 257 | 2022-10-20 |
| 2020-04-30 | Class II | Software design | The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit. | 4381 beds | 2024-01-23 |
| 2018-01-12 | Class II | Component change control | A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury. | 2117 | 2020-06-26 |
| 2017-02-23 | Class II | Software change control | The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period. | 3037 | 2017-09-19 |
| 2016-06-14 | Class II | Device Design | The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one | 24262 | 2017-05-15 |
| 2015-10-07 | Class II | Device Design | Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting. | 12251 units | 2017-02-10 |
| 2013-04-15 | Class II | Process control | Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame. | 8,737 devices | 2017-02-07 |
| 2012-06-18 | Class II | Process design | During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail. | 7843 devices | 2014-06-06 |
| 2011-02-21 | Not classified | Other | Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade. Because of an unauthori | 740 units | 2012-08-06 |
| 2011-02-21 | Not classified | Other | Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade. Because of an unauthori | 1609 | 2012-08-06 |
| 2011-02-21 | Not classified | Other | Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade. Because of an unauthori | 116 | 2012-08-06 |
| 2011-02-03 | Not classified | Software design | The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. The firm in | 905 beds. | 2012-09-26 |
| 2011-02-03 | Not classified | Software design | The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. The firm in | 40 beds. | 2012-09-26 |
| 2010-06-11 | Not classified | Process control | The firm received a complaint regarding the plastic housing used to support the trapeze handle. The firm investigated and found that the manufacturer of the trapeze handle didn’t correctly process the plastic component. Therefore the plas | 319 | 2011-02-18 |
| 2010-03-05 | Not classified | Device Design | The firm received complaints regarding the siderails not operating correctly or becoming inoperable. The siderails could experience false latching, unintentional lowering or become inoperable. There have been reports of 5 patient falls an | 1,406 beds both models. | 2014-10-06 |
| 2010-03-05 | Not classified | Device Design | The firm received complaints regarding the siderails not operating correctly or becoming inoperable. The siderails could experience false latching, unintentional lowering or become inoperable. There have been reports of 5 patient falls an | 1,406 beds both models. | 2014-10-06 |
| 2010-01-01 | Not classified | Nonconforming Material/Component | The controls for nurse call, bed movement and entertainment functions on the intermediate rail may fail to function. | 185 | 2012-02-17 |
| 2009-09-16 | Not classified | Device Design | The flexing of the junction of the sleep deck’s head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off. | 2,973 beds | 2012-03-16 |
| 2009-09-16 | Not classified | Device Design | The flexing of the junction of the sleep deck’s head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off. | 4,535 beds | 2012-03-16 |
| 2009-04-20 | Not classified | Process control | The siderails may exhibit false latching, or unintentional lowering, or may become inoperable. | 4017 beds | 2010-10-15 |
| 2009-04-13 | Not classified | Device Design | Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed. | 39,971 both products | 2011-06-06 |
| 2009-04-13 | Not classified | Device Design | Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed. | 39,971 both products | 2011-06-06 |
| 2009-03-09 | Not classified | Process control | An e-ring may not have been installed during production, which could result in an inability to latch the siderail. | 53 beds | 2010-10-13 |
| 2008-11-11 | Not classified | Other | Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exit | 567 | 2009-12-31 |
| 2008-04-28 | Not classified | Other | A risk of entrapment will exist between the head and foot rails if installation instructions are followed. | 69 | 2009-09-22 |
| 2008-04-08 | Not classified | Device Design | The upper deck may collapse to its lowest position and the caster brakes may fracture if the bed is moved while the brakes are locked. | 753 beds | 2010-10-13 |
| 2006-07-27 | Not classified | Other | The patient pendant cord represents a potential trip hazard for the patient or the caregiver. | 36,645 | 2008-04-10 |
| 2005-05-20 | Not classified | Other | Sleep bed pivot bolts may break, allowing the head section to shift or to drop to one side. | 218 | 2005-08-12 |
| 2005-03-01 | Not classified | Other | Siderails may stay up without latching into place. | 228 beds | 2005-07-18 |
| 2004-12-29 | Not classified | Other | A potential trip hazard exists when the fracture frame adaptor bracket is installed on the bed without the fracture frame. | 324 | 2005-05-09 |
| 2004-11-29 | Not classified | Other | Warning label containing instructions for proper electrical grounding was not attached. | 1,825 | 2005-06-02 |
| 2004-08-24 | Not classified | Other | Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing. | 5048 | 2005-01-31 |
| 2004-06-28 | Not classified | Other | An incorrect warning label was placed on these beds. Warning should say, “do not use for life sustaining equipment…..” | 180 | 2004-12-14 |
| 2004-03-08 | Not classified | Other | A potential pinch/shear point exists between the restraint strap hook located underneath the knee section and the foot rail mounting of the bed. | 294 | 2004-09-02 |
| 2003-12-26 | Not classified | Other | If fluid is spilled on the siderail or the bed control areas, the bed may change positions without user input. | 222 | 2004-05-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.