RESPIRONICS
Report
- Report Number
- 2518422-2025-052617
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Date of Event
- October 30, 2025
- Report Date
- December 17, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNT
- PMA / PMN Number
- K102985
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
USING THE SERIAL NUMBER, A DUPLICATE SEARCH WAS COMPLETED, AND THIS COMPLAINT WAS DETERMINED TO BE A DUPLICATE TO MRF #2518422-2025-051621. FURTHER INVESTIGATION AND REPORTING WILL BE COMPLETED WITHIN MRF #2518422-2025-051621.
E1: REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6).
PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR HAS A LOOSE OUTLET. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE CUSTOMER'S V60 VENTILATOR HAS A LOOSE OUTLET. ONSITE SERVICE WAS REQUESTED. THE DEVICE WAS SERVICED, AND THE SERVICE ENGINEER (SE) REPORTED THAT THE CENTRAL PROCESSING UNIT (CPU) TRAY COVER WAS DAMAGED. AFTER REPLACING THE CPU TRAY COVER, THE DEVICE WAS NOW SECURED TO THE CART. THE DEVICE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2317146 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS, INC. | V60 V60PLUS VENTILATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |