BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI DIAGNOST 4

    MDR report key: 2013407 · Received February 2, 2011

    Report

    Report Number
    3003768277-2011-00100
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 5, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAA
    PMA / PMN Number
    K961374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION SHOWS THAT THE FIELD SERVICE ENGINEER (FSE) TROUBLESHOOT THE SYSTEM AND FOUND THAT THE POWERSUPPLY OF THE II/TV CHAIN WAS BAD. HE REPLACED THE "(B)(4) - PSU REPLACEMENT KIT", WHICH SOLVED THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A COLLISION, WHICH WAS RESOLVED, THE FLUOROSCOPY DID NOT WORK. THE DEVICE WAS RESTARTED, THIS PRODUCED THE DESIRED RESULT. LATER IN THE MIDDLE OF THE EXAMINATION, THE DEVICE FAILED WITHOUT AN ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI DIAGNOST 4 JAA PHILIPS HEALTHCARE 708031

    Patients

    Seq Age Sex Outcome Treatment
    1