BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 24366625 · Received February 17, 2026

    Report

    Report Number
    2518422-2026-101897
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 29, 2026
    Report Date
    March 2, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER GOOD FAITH EFFORT (GFE) RESPONSE, IT WAS CONFIRMED THAT THE CUSTOMER RECEIVED A THIRD POWER CORD AND INSTALLED IT. GROUNDS TESTING WAS SUCCESSFUL; THE DEVICE PASSED THE ENTIRE PERFORMANCE VERIFICATION TESTING AND HAS BEEN 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.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM A BIOMEDICAL TECHNICIAN REGARDING A V60 VENTILATOR, NOTING WHILE PERFORMING PREVENTATIVE MAINTENANCE (PM) PERFORMANCE VERIFICATION TESTING (PVT), THE DEVICE FAILED THE ELECTRICAL SAFETY TEST, MEASURING 600 MILLIOHMS OF RESISTANCE. A REPLACEMENT POWER CORD WAS ORDERED AND INSTALLED; HOWEVER, IT WAS IDENTIFIED AS AN OUT-OF-BOX FAILURE (DEFOA) BY PHILIPS TECHNICAL SUPPORT. POINT-TO-POINT GROUND TESTING USING A CALIBRATED FLUKE METER CONFIRMED THE NEW POWER CORD WAS FAULTY. A SECOND WARRANTY REPLACEMENT POWER CORD WAS PROVIDED, BUT IT ALSO FAILED OUT OF THE BOX, WITH TESTING TODAY SHOWING A RESISTANCE OF OVER 100 MILI OHMS, AND WHEN CONNECTED TO THE DEVICE, THE GROUNDS TESTING WILL NOT PASS. THE CUSTOMER IS STILL OVER 200 MILI OHMS ON ALL TEST POINTS LISTED IN THE MANUAL. THERE WAS NO PATIENT INVOLVEMENT. DUE TO THE PENDING REPAIR OF THE POWER CORD, THE DEVICE HAS NOT YET BEEN TESTED FOLLOWING THE REPLACEMENT OF THE PRESSURE TRANSDUCER MODULE. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428821 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown