FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 9618370
·
Received January 22, 2020
Report
- Report Number
- 2031642-2020-00275
- Event Type
- Malfunction
- Date Received
- January 22, 2020
- Report Date
- January 8, 2020
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- MNT
- UDI-DI
- 00884838020054
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 01/22/2020.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TOUCHSCREEN COULD NOT BE CALIBRATED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 82689 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 | 00884838020054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |