IVENT 201 Adverse Event — Malfunction (MDR 2112667-2020-01357)
IVENT 201 Adverse Event — Malfunction (MDR 2112667-2020-01357) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: IVENT 201; Generic name: CRITICAL CARE VENTILATER; Manufacturer: DATEX-OHMEDA, INC..
| Device | IVENT 201 |
|---|---|
| Generic name | CRITICAL CARE VENTILATER |
| Manufacturer | DATEX-OHMEDA, INC. |
| Report number | 2112667-2020-01357 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE POWER SWITCH WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO REPORT OF PATIENT INVOLVEMENT. |
| Source | openFDA MAUDE (device adverse events) |
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