RESPIRONICS
Report
- Report Number
- 2518422-2026-112965
- Event Type
- Malfunction
- Date Received
- May 7, 2026
- Date of Event
- February 15, 2026
- Report Date
- May 19, 2026
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNT
- PMA / PMN Number
- K102985
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
(B)(6).
IT WAS REPORTED THAT AN OVERVOLTAGE PROTECTION (OVP) CIRCUIT FAILURE CIRCUIT FAILURE OCCURRED. PER GOOD FAITH EFFORT (GFE) RESPONSE, THE REPORTED ISSUE WAS CONFIRMED DUE TO THE DAMAGE ON THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). NO TROUBLESHOOTING OR TESTING INFORMATION WAS PROVIDED. THE CUSTOMER "REPAIRED" THE MC PCBA. GFE RESPONSE CONFIRMS CUSTOMER IS AWARE REPAIRS MADE ON THE MC PCBA ARE NOT ADVISED. NO FURTHER INFORMATION PROVIDED. THE CUSTOMER "REPAIRED" THE MC PCBA TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT AN OVERVOLTAGE PROTECTION (OVP) CIRCUIT FAILURE OCCURRED. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR USER. IT WAS REPORTED THAT AN OVP CIRCUIT FAILURE OCCURRED. THE INVESTIGATION IS ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115721 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS, INC. | V60 V60PLUS VENTILATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |