PNEUPAC PARAPAC VENTILATOR Adverse Event — Malfunction (MDR 3012307300-2020-03456)
PNEUPAC PARAPAC VENTILATOR Adverse Event — Malfunction (MDR 3012307300-2020-03456) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PNEUPAC PARAPAC VENTILATOR; Generic name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR); Report number: 3012307300-2020-03456.
| Device | PNEUPAC PARAPAC VENTILATOR |
|---|---|
| Generic name | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) |
| Report number | 3012307300-2020-03456 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | USER FACILITY |
| Narrative | ONE PNEUPAC PARAPAC VENTILATOR WAS RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION THE GAUGE BEZEL WAS OBSERVED TO BE CRACKED, CORROSION TO THE BATTERY HOLDER WAS FOUND, AND TWO CONTROL KNOBS WERE MISSING. THE DEVICE WAS POWERED ON FOLLOWING CONNECTING O2 SUPPLY; CONFIRMING THE COMPLAINT OF ALARMS. BASED ON THE EVIDENCE, THE ROOT CAUSE WAS FOUND DUE TO USER INTERFACE. |
| Source | openFDA MAUDE (device adverse events) |
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