PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 Adverse Event — Malfunction (MDR 2031702-2020-03453)
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 Adverse Event — Malfunction (MDR 2031702-2020-03453) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: VYAIRE MEDICAL.
| Device | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | VYAIRE MEDICAL |
| Report number | 2031702-2020-03453 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). THIRD PARTY SERVICE TECHNICIAN WAS NOT ABLE TO VERIFY CUSTOMER'S REPORTED PROBLEM. VENTILATOR WAS TESTED WITH A KNOWN GOOD AC ADAPTER AND KNOWN GOOD PATIENT CIRCUIT CONNECTED. VENT PASSED 87 HOURS EXTENDED TESTS. VENTILATOR PASSED INITIAL FINAL TEST AND INITIAL ALARM VOLUME TEST, WHICH INCLUDES MANY ALARM AND VENTILATION FUNCTIONS. REVIEW OF EVENT TRACE |
| Source | openFDA MAUDE (device adverse events) |
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