BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 24268589 · Received February 5, 2026

    Report

    Report Number
    2518422-2026-100510
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 17, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838009851
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ON 12FEB2026 THE BENCH SERVICE ENGINEER (BSE) AGAIN SERVICED THE DEVICE AND REPLACED THE FRONT BEZEL W/ NAV-RING TO RESOLVE THE ISSUE. THE BSE THEN COMPLETED A PERFORMANCE VERIFICATION TEST (PVT). THE DEVICE PASSED THE PVT, CONFIRMING A RETURN TO FULL FUNCTIONALITY. THE DEVICE IS BEING SENT BACK TO THE CUSTOMER READY FOR USE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE NAVIGATION RING (NAV-RING) WAS NOT WORKING. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. ON (B)(6) 2026, THE DEVICE WAS EVALUATED AT A BENCH SERVICE CENTER BY A BENCH SERVICE ENGINEER (BSE). THE BSE OBSERVED THE DEVICE WAS BEHAVING AS IF MANIPULATED EVEN WHEN NOT BEING TOUCHED. THE BSE STATED THAT ATTEMPTS HAD BEEN MADE TO CHECK IF THE NAV-RING HAD BEEN DISCONNECTED, BUT IT WAS CONFIRMED THAT IT HAD HADN'T BEEN DISCONNECTED. THE BSE DETERMINED THAT THE FRONT BEZEL WITH NAV-RING NEEDED TO BE REPLACED. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223408 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown