SERVO-I Adverse Event — Malfunction (MDR 8010042-2020-00252)
SERVO-I Adverse Event — Malfunction (MDR 8010042-2020-00252) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SERVO-I; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: MAQUET CRITICAL CARE AB.
| Device | SERVO-I |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Report number | 8010042-2020-00252 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | OUR FSE (FIELD SERVICE ENGINEER WAS ON SITE TO INVESTIGATE THE EVENT. THE FSE REPLACED PARTS SUCH AS PANEL PRINTED CIRCIT BOARD, TOUCH SCREEN, EXPIRATORY VALVE AND INSPIRATORY PIPE DUE TO UNIT BEING SUCKED INTO MRI MACHINE . DISLODGED EMC (ELECTROMAGNETIC COMPATIBILITY) ABSORBERS REPLACED AS WELL. AFTER THAT THE UNIT PASSED ALL FUNCTIONAL AND SAFETY CHECKS PER FACTORY SPECIFICATIONS. RETURNED TO C |
| Source | openFDA MAUDE (device adverse events) |
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