980 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00059)
980 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00059) 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 | 8020893-2020-00059 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | CORRECTION: SECTION D4 - SERIAL NUMBER CORRECTION: SECTION H6 - EVALUATION CODE METHOD, RESULT AND CONCLUSION DEVICE EVALUATION SUMMARY: THE SERVICE ENGINEER (SE) EVALUATED THE DEVICE AND REPLACED THE BREATH DELIVERY POWER CONTROLLER DISTRIBUTION PRINTED CIRCUIT BOARD. THE VENTILATOR PASSED ALL TESTING PER MANUFACTURING SPECIFICATION AND WAS RETURNED TO THE CUSTOMER. THE REPLACED COMPONENT WAS RET |
| Source | openFDA MAUDE (device adverse events) |
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