980 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00058)
980 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00058) 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 | 8020893-2020-00058 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | DEVICE EVALUATION SUMMARY: ALTHOUGH THE SERVICE ENGINEER WAS UNABLE TO DUPLICATE THE REPORTED ISSUE, A REVIEW OF THE VENTILATOR MEMORY LOGS PROVIDED, IT WAS ID ENTIFIED THAT THE PROBABLE CAUSE OF THE REPORTED EVENT WAS RELATED TO THE DIRECT CURRENT (DC) TO DC PRINTED CIRCUIT BOARD (PCB). THE SERVICE ENGINEER WAS NOTIFIED AND REPLACED THE DC-DC ON 2020-MAY-29. MEDTRONIC IS SUBMITTING THIS REPORT TO |
| Source | openFDA MAUDE (device adverse events) |
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