FDA Adverse Event
Malfunction
Summary report: N
RESPIRONICS
MDR report key: 11821683
·
Received May 13, 2021
Report
- Report Number
- 2031642-2021-03708
- Event Type
- Malfunction
- Date Received
- May 13, 2021
- Date of Event
- April 14, 2021
- Manufacturer
- RESPIRONICS CALIFORNIA, LLC
- Product Code
- MNT
- UDI-DI
- 00884838020054
- PMA / PMN Number
- K102985
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
A PHILIPS SERVICE ENGINEER CONFIRMED THE NAV-RING MALFUNCTION. THE FRONT BEZEL WAS REPLACED TO RESOLVE THE ISSUE. THE UI FRONT BEZEL ASSEMBLY WAS RETURNED FOR FAILURE INVESTIGATION. VISUAL INSPECTION OF THE UI FRONT BEZEL ASSEMBLY REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. THE NAV-RING POTENTIOMETER PRE-LOAD AND RESISTANCE MEASUREMENT TEST FAILED. CONTAMINATION BUILDUPS WERE FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY MATRIX THAT CAUSES THE NAV-RING NOT FUNCTIONING.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE NAV RING DOES NOT WORK. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713883 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS CALIFORNIA, LLC | V60 | 00884838020054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |