840 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00057)
840 VENTILATOR Adverse Event — Malfunction (MDR 8020893-2020-00057) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 840 VENTILATOR; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: COVIDIEN.
| Device | 840 VENTILATOR |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | COVIDIEN |
| Report number | 8020893-2020-00057 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, O |
| Narrative | DEVICE EVALUATION SUMMARY: A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND THAT THE ALTERNATING CURRENT (AC) LINE ASSEMBLY AND POWER SUPPLY UNIT NEEDED REPLACEMENT. THE VENTILATOR IS CURRENTLY AWAITING REPAIRS AT THIS TIME. IT WAS NOTED THAT THERE WERE NO BURN MARKS ON THE BREATH DELIVERY (BD) CENTRAL PROCESSING UNIT (CPU) OR ANALOG INTERFACE (AI) PRINTED CIRCUIT BOARD (PCB). IF THE REPAIRS |
| Source | openFDA MAUDE (device adverse events) |
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