BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21420526 · Received February 20, 2025

    Report

    Report Number
    2518422-2025-018769
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 5, 2025
    Report Date
    February 20, 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

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR DISPLAYED THAT THERE WAS NO OXYGEN BEING SUPPLIED. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT OR USER HARM REPORTED. THE KEY MARKET (KM) REPORTED THAT THE V60 VENTILATOR DISPLAYED THAT THERE WAS NO OXYGEN BEING SUPPLIED. A FOLLOW UP WAS PERFORMED WITH THE KM, AND IT WAS REPORTED THAT THERE WERE NO ERROR CODES BEING DISPLAYED ON THE DEVICE. THE KM RESPONDER REPORTED THAT THE OXYGEN CONCENTRATION OUTPUT BY THE OXYGEN CONCENTRATOR DID NOT MEET THE STANDARDS AND NOTED THAT THE DEVICE HAD LOW OXYGEN CONCENTRATION. THE KM THEN REPORTED THAT AFTER SWITCHING TO THE BUILT-IN OXYGEN SUPPLY MODE, THE DEVICE RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424768 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown