BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 V60PLUS VENTILATOR

    MDR report key: 20557863 · Received October 29, 2024

    Report

    Report Number
    2518422-2024-66809
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 22, 2024
    Report Date
    January 6, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838089280
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE AT A BENCH SERVICE CENTER AND FOUND THAT THE TOUCHSCREEN WAS NOT WORKING. THE BSE ATTEMPTED TO CALIBRATE THE TOUCHSCREEN, BUT THE DEVICE ISSUE DID NOT RESOLVE. THE BSE DETERMINED THAT THE TOUCHSCREEN NEEDED TO BE REPLACED. THE BSE REPLACED THE TOUCHSCREEN TO RESOLVE THE TOUCHSCREEN NOT RESPONDING ISSUE. FOLLOWING THE PART REPLACEMENT THE BSE COMPLETED A PERFORMANCE VERIFICATION TEST (PVT) WHICH THE DEVICE PASSED. THE BSE RESTORED THE DEVICE'S FACTORY SETTINGS, CONFIRMED THE DEVICE WAS FULLY FUNCTIONAL, AND WILL RETURN THE DEVICE 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 TOUCHSCREEN WAS NOT WORKING. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. A BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE AT A BENCH SERVICE CENTER AND FOUND THAT THE TOUCHSCREEN WAS NOT WORKING. THE BSE ATTEMPTED TO CALIBRATE THE TOUCHSCREEN, BUT THE DEVICE ISSUE DID NOT RESOLVE. THE BSE DETERMINED THAT THE TOUCHSCREEN NEEDED TO BE REPLACED. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322148 V60 V60PLUS VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838089280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown