Standard Hard Paddles
Paddle Assy-Detachable,rohs,eng
3manufacturers in China registered for this device type
1catalogue number
17510(k) clearances naming this product code
21recalls on this code
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Physio-Control, Inc., United States |
|---|---|
| FDA product code | LDD |
| Device type | Dc-Defibrillator, Low-Energy, (Including Paddles) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-04-15 |
| Record revised | 2023-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11130 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unipower | Unipower Corp. | 623 |
| Internal Handle | Zoll Medical Corporation | 89 |
| Vermed | Nissha Medical Technologies Limited | 47 |
| Cardio Clear | Cardio Medical Products, Inc. | 33 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Fiab SPA | 20 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | Physio-Control, Inc. | 20 |
| R2 | ConMed Corporation | 17 |
| HeartStart | Philips Medical Systems Hsg | 9 |
| Anybattery | Anybattery, Inc | 6 |
| Tempus LS-Manual | Remote Diagnostic Technologies Ltd. | 6 |
| Vermed Defib Pads | Graphic Controls Acquisition Corporation | 5 |
| HeartStart | Philips Electronics North America Corporation | 4 |
Showing 12 of 29. All products under Dc-Defibrillator, Low-Energy, (Including Paddles)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182503 | 2019-06-03 |
| K922315 | 1994-03-16 |
| K935674 | 1993-12-16 |
| K931053 | 1993-05-18 |
| K912966 | 1992-02-21 |
| K910144 | 1991-07-17 |
| K902288 | 1991-02-25 |
| K905510 | 1990-12-20 |
| K902478 | 1990-10-31 |
| K895379 | 1990-02-26 |
| K890079 | 1989-02-23 |
| K883617 | 1988-12-28 |
| K881153 | 1988-07-27 |
| K871224 | 1987-05-20 |
| K832833 | 1984-10-26 |
| K842624 | 1984-10-18 |
| K843229 | 1984-10-18 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2024-08-09 | Class II | Under Investigation by firm | Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles. | 3,617 devices (US-3315 and O.U.S – 302 devices) | |
| 2009-02-16 | Not classified | Other | Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling. | TOTAL: 3218 units; 2052 in the US, 1166 internationally | 2011-08-17 |
| 2008-12-30 | Not classified | Employee error | When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform. | 23,467 units worldwide | 2011-11-21 |
| 2008-11-17 | Not classified | Labeling False and Misleading | Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments. | 1689 units | 2010-09-28 |
| 2008-11-17 | Not classified | Labeling False and Misleading | Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments. | 38,185 units | 2010-09-28 |
| 2008-05-13 | Not classified | Device Design | A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mo | 24 units | 2011-03-20 |
| 2008-05-13 | Not classified | Device Design | A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by | 1,219 units | 2011-03-20 |
| 2008-05-13 | Not classified | Device Design | A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mo | 78 keypads | 2011-03-20 |
| 2008-04-16 | Not classified | Software design | The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shoc | 969 units | 2011-03-29 |
| 2008-04-16 | Not classified | Software design | The LIFEPAK 20 defibrillator / monitors with software versions 048, 052 and 054 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly re | 21,102 units | 2011-03-29 |
| 2008-04-16 | Not classified | Software design | The LIFEPAK 12 defibrillator / monitors with software version 130 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock | 19,805 units | 2011-03-29 |
| 2008-01-29 | Not classified | Labeling design | Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately and are used on a patient, there is a ris | 2011-05-04 | |
| 2008-01-29 | Not classified | Labeling design | Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately and are used on a patient, there is a ri | 47,274 worlwide for Defibrillator Handles and Paddles | 2011-05-04 |
| 2006-08-30 | Not classified | Other | Devices with v38 system software do not display a ”LOW BATTERY: CONNECT TO AC POWER” message when the monitor is on backup (DC) battery power and may shut down without warning. | 2,831 worldwide | 2011-03-25 |
| 2006-03-22 | Not classified | Nonconforming Material/Component | Therapy connectors may have connector sockets that do not meet design specs – short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions. | 2678 devices | 2011-09-06 |
| 2006-03-16 | Not classified | Other | LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power. | 10,307 devices as of 9-19-06 | 2011-03-29 |
| 2005-09-02 | Not classified | Other | Potential for voltage pins in connector of therapy cable to break. | 2011-01-17 | |
| 2005-09-02 | Not classified | Other | Potential for voltage pins in connector of therapy cable to break. | total for both types – 52,654 | 2011-01-17 |
| 2005-06-17 | Not classified | Other | The defibrillator may not operate if the device is turned on during an AC Loss Alert. | 3924 units | 2006-05-06 |
| 2004-05-05 | Not classified | Other | The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor. | 1689 | 2005-01-06 |
| 2004-04-05 | Not classified | Other | Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator. | 2885 | 2005-01-06 |
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.