BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEM MX8000IDT SCANNER

    MDR report key: 952513 · Received November 19, 2007

    Report

    Report Number
    1525965-2007-00035
    Event Type
    Malfunction
    Date Received
    November 19, 2007
    Date of Event
    August 9, 2007
    Report Date
    August 9, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TEAL HAS UL ELECTRICAL SAFETY APPROVAL, AND THE RISK OF INJURY TO A PATIENT IS REMOTE. THIS ISSUE WAS FOUND DURING THE REVIEW OF INTERNAL SERVICE RECORDS. THIS ISSUE WAS NOT CONFIRMED UNTIL NOVEMBER 19, 2007. VOLUNTARY MEDICAL DEVICE RECALL REPORT WAS FILED. IT HAS BEEN CLASSIFIED AS A CLASS 2 RECALL. PMS ISSUED MANDATORY FIELD CHANGE ORDER TO CORRECT THIS ISSUE. THE ROOT CAUSE OF THE ISSUE IS A COMPONENT FAILURE ON THE VENDED DEVICE.

    Description of Event or Problem · 1

    THE USER REPORTED: POWER CONDITIONER SMOKING/SYSTEM IS DOWN: CUSTOMER STATES THEY HAVE SHUTDOWN POWER TO POWER CONDITIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEM MX8000IDT SCANNER COMPUTED TOMOGRAPHY SCANNER JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR