BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 2173660 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10667
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 26, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMMUNICATOR WAS RETURNED WITH BOTH THE POWER BRICK AND PHONE CORD. A VISUAL INSPECTION REVEALED NO PHYSICIAL DAMAGE. THE POWER BRICK DID NOT SUCCESSFULLY PASS THE VOLTAGE CHECK. FURTHER ANALYSIS REVEALED THE OUTSIDE CASE OF THE POWER BRICK WAS MELTED, BUT DID NOT GET HOT DURING TESTING IN THE LABORATORY. A REPLACEMENT POWER BRICK WAS USED TO POWER UP THE COMMUNICATOR AND THE UNIT PASSED ALL BASELINE TESTS. LABORATORY ANALYSIS CONFIRMED THE OBSERVATIONS OF A MELTED POWER BRICK.

    Additional Manufacturer Narrative · 1

    LATITUDE PATIENT SERVICES SENT THE PATIENT A RETURN LABEL AND REQUESTED THE PATIENT RETURN THE UNIT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT REPORTED THEIR POWER BRICK MELTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMUNICATOR ACCESSORY LWS EXTERNAL MANUFACTURER 6482

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 0185| E030| T177