VAR (VORTRAN Automatic Resuscitator)
VORTRAN MEDICAL TECHNOLOGY 1, INC · Model PC-5010 · UDI-DI 10637320050100
Description
The VAR® device is a unique single-patient-use, disposable resuscitator. It provides hands-free ventilator support via a mask or endotracheal tube using a continuous gas flow source. The VAR® device can be operated on a compressor, oxygen or compressed air. Since it does not require the use of electricity or batteries, it is an ideal backup ventilator for the management of mass casualty incidents, natural disasters, disease outbreaks, major power outages and other extraordinary emergencies. An additional advantage of the VAR® device is that it does not interfere with MRI and CT scans.
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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