BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS HEALTHCARE

    MDR report key: 6313794 · Received February 7, 2017

    Report

    Report Number
    MW5067759
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    February 3, 2017
    Report Date
    February 7, 2017
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE V60 VENTILATOR WAS SENT TO BIOMED FOR REPAIR. WHILE TROUBLESHOOTING THE UNIT, BIOMED NOTICED AN ERROR CODE 100A FROM THE EVENT LOG HISTORY. WHEN CONTACTED PHILIPS FOR TECHNICAL SUPPORT, BIOMED WAS TOLD THAT THIS ERROR CODE WAS DUE TO THE LOSS OF COMMUNICATION FROM DA PCBA TO MC PCBA CABLE AND NEEDS RETROFITTING. ALSO, WHEN CALLED, PHILIPS SAID THERE IS NO RECALL ISSUED AS OF NOW ON THIS AND IS BEING DEALT WITH ON A NEED BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92592 PHILIPS HEALTHCARE VENTILATOR MNT PHILIPS HEALTHCARE V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention