BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1170334 · Received September 11, 2008

    Report

    Report Number
    3023750-2008-00218
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K021766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. THE COMPLAINT WAS CONFIRMED AND CAUSED BY THE DISPLAY. REPLACEMENT OF THE DISPLAY RESOLVED THE ISSUE. A SECONDARY FINDING NOT RELATED TO THE COMPLAINT WAS THAT THE DEVICE WOULD INITIALIZED USING A BATTERY BUT NOT USING AUXILIARY POWER. THE CAUSE OF THIS FAILURE WAS DUE TO MULTIPLE DAMAGED COMPONENTS ON THE POWER SUPPLY CIRCUIT BOARD THAT SHOW INDICATIONS OF A SHORT CIRCUIT. CAUSE OF THE DAMAGE CANNOT BE IDENTIFIED TO THE COMPONENT LEVEL DUE TO THE DAMAGE. VISUAL INSPECTION IDENTIFIED THAT TWO SECURING SCREWS, AND THE CHASSIS SEAL WERE MISSING, AND MULTIPLE INTERNAL CABLES WERE NO LONGER ROUTED IN THE APPROPRIATE LOCATIONS. REPLACEMENT OF THE DISPLAY AND POWER SUPPLY CIRCUIT BOARD RESOLVED THE ISSUES. UPON COMPLETION OF REPAIRS, THE DEVICE PASSED RELEASE TESTING AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE LOWER SECTION OF THE DISPLAY IS BLANK. A SECONDARY FINDING NOT RELATED TO THE COMPLAINT WAS THAT THE DEVICE WOULD INITIALIZE USING A BATTERY BUT NOT USING AUXILIARY POWER. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC PIC 50

    Patients

    Seq Age Sex Outcome Treatment
    1