SERVO-S Adverse Event — Malfunction (MDR 8010042-2020-00250)
SERVO-S Adverse Event — Malfunction (MDR 8010042-2020-00250) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SERVO-S; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: MAQUET CRITICAL CARE AB.
| Device | SERVO-S |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Report number | 8010042-2020-00250 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | IT WAS REPORTED THAT DURING PATIENT USE, THE EXHALED TIDAL VOLUME WAS ABNORMAL. DURING ON-SITE INSPECTION OUR FIELD SERVICE TECHNICIAN FOUND THAT THE BREATHING TUBE WAS LEAKING. THE O2 CELL/SENSOR TEST FAILED DUE TO AN EXPIRED O2 CELL. AFTER REPLACEMENT, PRE-USE CHECK TESTS PASSED. NO PART WAS RETURNED. THE EVALUATION OF RECEIVED DEVICE LOGS SHOWS THAT ALL PRE-USE CHECKS BETWEEN (B)(6) 2019 AND (B |
| Source | openFDA MAUDE (device adverse events) |
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