BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 25217418 · Received May 19, 2026

    Report

    Report Number
    2518422-2026-113061
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 21, 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

    (B)(6).

    Additional Manufacturer Narrative · 0

    A GOOD FAITH EFFORT (GFE) RESPONSE WAS RECEIVED FROM THE AUTHORIZED SERVICE PROVIDER (ASP) ON (B)(6) 2026. THE ASP DID NOT PROVIDE THE DIAGNOSTIC REPORT (DRPT) FROM THE TIME OF THE EVENT. IT WAS CLARIFIED THAT THE DEVICE USE AT THE TIME OF THE EVENT WAS OUTSIDE OF USE, PRIOR TO USE ON A PATIENT. THE ASP STATED THAT THE CUSTOMER HIRED A THIRD PARTY TO REPAIR THE DEVICE. THE REPAIR WORK IS STILL ONGOING.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A PRESSURE SENSOR AUTOZERO FAILED ALARM. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. A PATIENT WAS ADMITTED ON (B)(6) 2026 WITH A DIAGNOSIS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ACCOMPANIED BY AN ACUTE LOWER RESPIRATORY TRACT INFECTION, AND WITH A HISTORY OF "RECURING COUGHING AND EXPECTORATION ACCOMPANIED BY SHORTNESS OF BREATH FOR OVER 20 YEARS, WITH AN EXACERBATION LASTING MORE THAN HALF A MONTH." ON (B)(6) 2026, FOLLOWING A PHYSICIAN'S ORDERS, THE ASSIGNED NURSE INITIALED USE OF THE NON-INVASIVE VENTILATION SUPPORT WITH A V60 TO TREAT THE TYPE 2 RESPIRATORY FAILURE. PRIOR TO USE ON THE PATIENT, A ROUTINE INSPECTION OF THE NON-INVASIVE VENTILATOR WAS CONDUCTED; THE DEVICE APPEARED PHYSICALLY INTACT, ITS LABELING WAS CLEAR, AND IT REMAINED WITHIN ITS VALID SERVICE LIFE. UPON POWERING ON THE DEVICE, THE SCREEN DISPLAYED A MESSAGE: "VENTILATOR NOT WORKING, 1007: MACHINE AND PROXIMAL PRESSURE SENSOR FAILURE." THE MACHINE THEN ALARMED FOR CHECK VENT: MACHINE PRESSURE SENSOR AUTOZERO FAILED. THE EVENT WAS REPORTED TO THE HEAD NURSE, AND A BACKUP NON-INVASIVE VENTILATOR WAS SUBSTITUTED. THE REPLACEMENT DEVICE PASSED ITS POWER-ON SELF-TEST WITHOUT ISSUE AND WAS PLACED INTO USE. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167829 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1