980 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00056)
980 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00056) 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 | 8020893-2020-00056 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, O |
| Narrative | CORRECTION: SECTION G = 510K NUMBER ADDITIONAL INFORMATION: THE MEDTRONIC FIELD SERVICE ENGINEER EVALUATED THE VENTILATOR AND REPORTED THAT THE VENTILATOR HAD BEEN OUT OF CLINICAL USE AND IN STORAGE SINCE SOMETIME IN 2015. THE VENTILATOR WAS RECENTLY RETURNED TO CLINICAL USE WITH UPGRADED SOFTWARE WHEN IT WENT INTO BACKUP VENTILATION WHILE IN USE ON A PATIENT. THE VENTILATOR HAS NOT BEEN REPAIRED. |
| Source | openFDA MAUDE (device adverse events) |
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