V60 VENTILATOR Adverse Event — Malfunction (MDR 2031642-2020-01582)
V60 VENTILATOR Adverse Event — Malfunction (MDR 2031642-2020-01582) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: V60 VENTILATOR; Generic name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY; Manufacturer: RESPIRONICS CALIFORNIA, INC.
| Device | V60 VENTILATOR |
|---|---|
| Generic name | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY |
| Manufacturer | RESPIRONICS CALIFORNIA, INC |
| Report number | 2031642-2020-01582 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, USER FACILITY |
| Narrative | G4: 09JUL2020 B4: (B)(6)2020. THE DEVICE WAS REPORTED TO BE IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO REPORTED PATIENT OR USER HARM. THE CUSTOMER REFUSED THE SERVICE QUOTE. NO REPAIR SERVICE WAS PERFORMED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED O |
| Source | openFDA MAUDE (device adverse events) |
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