FLOW-I Adverse Event — Malfunction (MDR 8010042-2020-00242)
FLOW-I Adverse Event — Malfunction (MDR 8010042-2020-00242) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FLOW-I; Generic name: GAS-MACHINE, ANESTHESIA; Manufacturer: MAQUET CRITICAL CARE AB.
| Device | FLOW-I |
|---|---|
| Generic name | GAS-MACHINE, ANESTHESIA |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Report number | 8010042-2020-00242 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION FAILED THE PRESSURE TRANSDUCER TEST AND THE AUTOMATIC VENTILATION LEAKAGE TEST DURING SYSTEM CHECK OUT. THERE WAS NO PATIENT CONNECTED TO THE WORKSTATION AT THE TIME OF THE EVENT. MANUFACTURER´S REF #: (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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