BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KITS

    MDR report key: 1952217 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23549
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    October 25, 2010
    Report Date
    December 23, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    VOLTAGE TESTING OF THE POWER BRICK INITIALLY FOUND THAT THE UNIT DID NOT OUTPUT THE AMOUNT OF ENERGY AS EXPECTED AND THE GREEN LED DID NOT ILLUMINATE. HOWEVER, AFTER THE POWER BRICK EXHIBITED EXCESSIVE TEMPERATURES WHEN IT WAS RETURNED, THE GREEN LED DID ACTIVATE AND THE OUTPUT REACHED THE APPROPRIATE OUTPUT. THE TEMPERATURE THEN STARTED TO DECREASE. THE MANUFACTURER CONCLUDED THAT THE OBSERVATIONS OF EXCESSIVE TEMPERATURE WAS A RESULT A COMPONENT MALFUNCTION THAT OCCURRED IN THE POWER BRICK.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LATITUDE POWER CORD WAS ANALYZED. AFTER THIS LATITUDE POWER CORD HAD BEEN PLUGGED IN FOR 20 MINUTES, IT BECAME EXCESSIVELY HOT TO TOUCH, A BURNING SMELL WAS NOTICED, AND AS A RESULT THE CASE MELTED. LABORATORY ANALYSIS CONFIRMED THE FIELD OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PHYSICIAN BELIEVED THE TRANSFORMER OF THIS LATITUDE POWER CORD BURNT OUT DUE TO THE SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KITS ACCESSORY OEZ EXTERNAL MANUFACTURER 6467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other