UNI-VENT, MODEL 731 Adverse Event — Malfunction (MDR 1220908-2020-01170)
UNI-VENT, MODEL 731 Adverse Event — Malfunction (MDR 1220908-2020-01170) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNI-VENT, MODEL 731; Generic name: VENTILATOR; Manufacturer: ZOLL MEDICAL CORPORATION.
| Device | UNI-VENT, MODEL 731 |
|---|---|
| Generic name | VENTILATOR |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Report number | 1220908-2020-01170 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN |
| Narrative | ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. THE COMPRESSOR WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE. |
| Source | openFDA MAUDE (device adverse events) |
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