BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 V60PLUS VENTILATOR

    MDR report key: 20514118 · Received October 23, 2024

    Report

    Report Number
    2518422-2024-64943
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    October 22, 2024
    Report Date
    December 20, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024 THE BENCH SERVICE ENGINEER (BSE) REPLACED THE ALTERNATING CURRENT (AC) POWER CORD TO RESOLVE THE OUT OF LIMIT RESISTANCE 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.

    Additional Manufacturer Narrative · 0

    H11: CORRECTION TO B5, THIS STATEMENT WAS INCLUDED IN ERROR: "THE BSE DETERMINED THAT THE TOUCHSCREEN NEEDED TO BE REPLACED."

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT ALTERNATING CURRENT (AC) POWER CABLE RESISTANCE EXCEEDED THE ALLOWABLE LIMITS. 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 COMPLETED AN ELECTRICAL SAFETY TEST. THE BSE FOUND THAT THE AC POWER CABLE RESISTANCE WAS OUT OF SPECIFICATION AND DETERMINED THAT A REPLACEMENT AC POWER CORD WOULD BE REQUIRED TO RESOLVE THE ISSUE. 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
    317017 V60 V60PLUS VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown