BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 23717897 · Received December 4, 2025

    Report

    Report Number
    2518422-2025-058836
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 4, 2025
    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

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR WAS EXPERIENCING LOW OXYGEN PRESSURE AND LOW SUCTION PRESSURE. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. A FOLLOW UP WAS PERFORMED WITH THE KEY MARKET (KM), AND THE RESPONDER REPORTED THAT THERE WAS NO MALFUNCTION WITH THE V60 VENTILATOR. THE KM REPORTED THAT THE ISSUE WAS DUE TO THE OXYGEN SUPPLY BEING LOW. IT WAS REPORTED THAT NO REPAIRS WERE REQUIRED, AND 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
    2120352 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown