BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEALTHCARE ANESTHESIA MONITOR

    MDR report key: 5541472 · Received March 29, 2016

    Report

    Report Number
    MW5061406
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    March 27, 2016
    Report Date
    March 29, 2016
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    CAPACITOR IN POWER SUPPLY EXPLODED IN THE OPERATION ROOM. MONITOR CHANGED. PATIENT UNHARMED. EQUIPMENT REGULARLY CHECKED BY HOSPITAL BIOMED DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188718 PHILIPS HEALTHCARE ANESTHESIA MONITOR MONITOR ANESTHESIA CCK PHILIPS HEALTHCARE M8033C

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR