BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 23922563 · Received December 30, 2025

    Report

    Report Number
    2518422-2025-059122
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 19, 2025
    Report Date
    January 15, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WAS PERFORMED WITH THE KEY MARKET (KM), AND THE RESPONDER REPORTED THAT THE CUSTOMER DECLINED TO HAVE THE BATTERY REPLACED, AS THE BATTERY WAS NO LONGER UNDER WARRANTY. THE KM DID NOTE THAT THE BATTERY WAS REMOVED, AND THE POWER SUPPLY WAS USED INSTEAD. THE KM NOTED THAT THE DEVICE WAS WORKING NORMALLY. NO FURTHER DETAILS WERE PROVIDED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR HAD A BATTERY FAILURE. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER REPORTED THAT THE DEVICE HAD A BATTERY FAILURE. PER THE DETAILS NOTED, THE RECOMMENDED ON-SITE REPAIR WAS TO HAVE THE AGENT REPAIR THE BATTERY FAILURE. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272139 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown