BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 V60PLUS VENTILATOR

    MDR report key: 24390028 · Received February 19, 2026

    Report

    Report Number
    2518422-2026-102810
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 18, 2026
    Report Date
    February 19, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838089280
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1: REPORTING ADDRESS STATE: (B)(6). REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT A NAV-RING FAILURE OCCURRED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS DISCOVERED ONSITE THAT A NAV-RING FAILURE OCCURRED. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) WENT ONSITE TO INVESTIGATE AND DISCOVERED THAT THERE WAS A NAV-RING FAILURE. THE PHILIPS ASP REPLACED THE NAV-RING TO RESOLVE THE REPORTED ISSUE. THE PHILIPS ASP REPLACED THE NAV-RING 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451573 V60 V60PLUS VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838089280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown