CAREvent PAR
CAREvent PAR assists the rescuer in providing efficient and effective CPR by providing with audible and visual prompts for chest compression, ventilation timing and automatic ventilation.…
CAREvent PAR assists the rescuer in providing efficient and effective CPR by providing with audible and visual prompts for chest compression, ventilation timing and automatic ventilation. The visual prompts aid the rescuer in their CPR efforts by providing illuminated pictograms of the CPR process, timed with the audible voice prompts. These voice and visual prompts help to significantly reduce interruptions in chest compression. The audible and visual warnings of mask leakage or airway obstruction assist the rescuer in ensuring that adequate tidal volumes are delivered.
Who Else Makes It
Concentrated in Guangdong (3), Fujian (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Dongguan Plastiflex Hose Technology Ltd | Dongguan | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | O-TWO Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | BTL |
| Device type | Ventilator, Emergency, Powered (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5925 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K081330 |
| Record published | 2016-02-03 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 60 °C |
| Sizes | Weight 1.2 kg; height 3.1 in; width 9.6 in; length 9.8 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01CV0100 | Weight 1.2 kg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Life Support Products | Allied Medical LLC | 50 |
| Neo-Tee T-Piece Resuscitator | Mercury Medical Enterprises, LLC | 45 |
| Pneupac | ICU Medical, Inc | 38 |
| Allied Medical LLC | Allied Medical LLC | 19 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 18 |
| AincA | Anesthesia Associates, Inc. | 17 |
| Neo-Tee T-Piece Resuscitator Circuit | Mercury Medical Enterprises, LLC | 12 |
| Life Support Products (LSP) | Allied Medical LLC | 12 |
| Moves | Thornhill Research Inc. | 11 |
| Ventlab | Ventlab, LLC | 7 |
| Resusa-Tee T-Piece Resuscitator | Mercury Medical Enterprises, LLC | 7 |
| Curaplex | Bound Tree Medical, LLC | 5 |
Showing 12 of 70. All products under Ventilator, Emergency, Powered (Resuscitator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141595 | 2015-03-16 |
| K093862 | 2010-05-06 |
| K081330 | 2009-03-06 |
| K051469 | 2005-09-28 |
| K051889 | 2005-08-30 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-02-12 | Class I | Process control | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main boa | 119 | 2023-06-29 |
| 2019-02-12 | Class I | Process control | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main boa | 136 | 2023-06-29 |
| 2019-02-12 | Class I | Process control | There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main boa | 632 | 2023-06-29 |
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.