FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 8919122
·
Received August 21, 2019
Report
- Report Number
- 2031642-2019-06872
- Event Type
- Malfunction
- Date Received
- August 21, 2019
- Report Date
- April 4, 2018
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- MNT
- UDI-DI
- 00884838020054
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: (B)(6). DATE OF REPORT: 21AUG2019. THE UNIT HAS BEEN REPAIRED AND RETURNED TO SERVICE. THE PART WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION: IT WAS DETERMINED CONTAMINATION BUILDUPS WERE FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV RING) MATRIX OF THE NEW NAV-RING PRODUCTION PROCESS THAT CAUSES THE NAV RING NOT FUNCTIONING. 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 CUSTOMER REPORTS NAV-RING FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712819 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 | 00884838020054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |