980 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00060)
980 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00060) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 980 VENTILATOR; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: COVIDIEN.
| Device | 980 VENTILATOR |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | COVIDIEN |
| Report number | 8020893-2020-00060 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | DEVICE EVALUATION SUMMARY; THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND THE UI (USER INTERFACE) PCB (PRINTED CIRCUIT BOARD) BURNT. THE SE REPLACED THE UI PCB, BATTERY, AND THE BDU (BREATH DELIVERY UNIT) POWER SUPPLY. THE VENTILATOR PASSED ALL TESTING PER MANUFACTURING SPECIFICATION AND WAS PLACED BACK INTO CLINICAL USE. IF THE REPLACED PARTS ARE RETURNED FOR FAILURE INVESTIGATION, A SU |
| Source | openFDA MAUDE (device adverse events) |
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