BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21894406 · Received April 23, 2025

    Report

    Report Number
    2518422-2025-044287
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    April 7, 2025
    Report Date
    April 28, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: REPORTING ADDRESS STATE: (B)(6). REPORTING ADDRESS POSTAL: (B)(6). REPORTER PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    ON 23APR2025, THE BENCH SERVICE ENGINEER (BSE) REPLACED THE TOUCHSCREEN TO RESOLVE THE ISSUE. FOLLOWING THE PART REPLACEMENT, THE BSE CONFIRMED THAT THE DEVICE WAS FULLY FUNCTIONAL BY COMPLETING A PERFORMANCE VERIFICATION TEST (PVT) WHICH THE DEVICE PASSED. THE DEVICE WILL BE RETURNED TO THE CUSTOMER READY FOR USE. 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 ON THE V60 VENTILATOR INDICATING THAT THE TOUCHSCREENS DETECTED TOUCH POSITION WAS OFF FROM THE ACTUAL TOUCH POSITION. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER RECEIVED THE DEVICE BACK AT THEIR SITE AND STATED THAT THE TOUCHSCREEN ISSUE WAS OBSERVED OUT OF THE BOX. THE CUSTOMER REQUESTED BENCH SERVICE BY A BENCH SERVICE ENGINEER (BSE), AND THE DEVICE WAS RECEIVED AT THE BENCH ON 07APR2025. ON 16APR2025, THE BSE EVALUATED THE DEVICE AND COULD NOT DUPLICATE THE TOUCHSCREEN ISSUE. NO FAULTS WERE FOUND DURING THE BSE'S EVALUATION. HOWEVER, WHEN THE BSE CHECKED THE DEVICE DIAGNOSTIC REPORT (DRPT), IT WAS SEEN THAT THERE WERE REPEATED INSTANCES OF "100% O2 ACTIVATION" FOLLOWED BY IMMEDIATE "O2 CANCEL" ACTIONS. THE BSE STATED THAT THIS COULD BE INDICATIVE OF AN INTERMITTENT TOUCHSCREEN ISSUE, SO THE BSE WILL REPLACE THE TOUCHSCREEN AS A PREVENTATIVE MEASURE. FURTHER SERVICE IS PENDING. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273736 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown