FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 8883640
·
Received August 12, 2019
Report
- Report Number
- 2031642-2019-05825
- Event Type
- Malfunction
- Date Received
- August 12, 2019
- Report Date
- December 1, 2017
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
(B)(6). DATE OF REPORT: 12AUG2019. THE MANUFACTURER'S FIELD SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) REPLACED THE DEFECTIVE FRONT BEZEL TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER A REQUEST FROM THE FDA ON MARCH 1, 2019 TO REVIEW COMPLAINTS FROM 29 NOV 2017 TO 29 NOV 2018. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.
Description of Event or Problem · 1
THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) ENCOUNTERED THE NAVIGATION RING FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678302 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |