BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI DIAGNOST 3

    MDR report key: 1971727 · Received December 29, 2010

    Report

    Report Number
    3003768277-2010-00412
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    JAA
    PMA / PMN Number
    K904012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS & RESULTS) - THE INVESTIGATION FOUND THE PROBLEM WAS SOLVED BY REPLACING A DEFECTIVE 1.25A FUSE ON THE EN168 BOARD. THE EXACT ROOT CAUSE IS UNK. REPLACEMENT OF A DEFECTIVE 1.25A FUSE WHICH MIGHT HAS CONTRIBUTED OR CAUSED THE REPORTED PROBLEM AND WHICH THEREFORE IS SUSPECT HAS SOLVED THE PROBLEM. THIS COMPONENT HAS NO EXCEPTIONAL OR INCREASED FAILURE RATE. FAILURE RATES AND RELIABILITY OF COMPONENTS ARE MONITORED. THERE IS NO REQUIRED MANDATORY FIELD ACTION.

    Description of Event or Problem · 1

    THE X-RAY SYSTEM DID NOT PROVIDE X RAY IN EITHER FLUOROSCOPY OR IN RADIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI DIAGNOST 3 JAA (X-RAY FLUOROSCOPIC, IMAGE INTENSIFIED, SYSTEM) JAA PHILIPS MEDICAL SYSTEMS 708030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1