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CAREvent PAR
O-Two Medical Technologies Inc · Model 01CV0100 · UDI-DI 07540195025349
BTL
Prescription
1
510(k) clearances
4,749
Adverse events (34 deaths)
29
Recalls
47
Facilities
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-10 | Mercury Enterprises, Inc. dba Mercury Medical | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and |
| 2024-08-30 | Mercury Enterprises, Inc. dba Mercury Medical | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. |
| 2024-05-31 | Smiths Medical ASD Inc. | Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the activ |
| 2024-05-31 | Smiths Medical ASD Inc. | There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. |
| 2024-05-31 | Smiths Medical ASD Inc. | Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the activ |
| 2024-05-31 | Smiths Medical ASD Inc. | There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. |
| 2024-02-07 | Smiths Medical ASD Inc. | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cyclin |
| 2024-02-07 | Smiths Medical ASD Inc. | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cyclin |
| 2021-07-15 | Smiths Medical ASD Inc. | Two devices were labeled with the same serial number |
| 2020-06-26 | Precision Valve & Automation,Inc | While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false ala |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.