LTV 1000 VENTILATOR Adverse Event — Malfunction (MDR 2031702-2020-03469)
LTV 1000 VENTILATOR Adverse Event — Malfunction (MDR 2031702-2020-03469) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LTV 1000 VENTILATOR; Generic name: VENTILATOR, CONTINUOUS, FACILITY USE; Manufacturer: VYAIRE MEDICAL.
| Device | LTV 1000 VENTILATOR |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Manufacturer | VYAIRE MEDICAL |
| Report number | 2031702-2020-03469 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). EQUIPMENT WAS RECEIVED IN HOUSE AT THE VYAIRE MEDICAL FACILITY IN PALM SPRINGS, CA. FOR EVALUATION. THE UNIT WAS PLACED ON EXTENDED TESTS/RUN-IN. NO ROOT CAUSE HAS BEEN DETERMINED YET SINCE INVESTIGATION IS STILL ONGOING. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. |
| Source | openFDA MAUDE (device adverse events) |
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