BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 2053099 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03873
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    August 8, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS CONSIDERED CLOSED. IF ADDITIONAL INFORMATION IS PROVIDED THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A FULL ANALYSIS OF THE PRODUCT WAS COMPLETED. THE COMMUNICATOR WAS RETURNED WITH THE POWER BRICK AND VISUAL INSPECTION REVEALED A DISENGAGED STRAIN RELIEF LEADING TO THE CORD ON THE POWER BRICK; IT WAS ALSO NOTED THAT THE POWER BRICK WAS DEFORMED FROM HEAT. A BURNING SMELL WAS ALSO NOTICED. THE POWER BRICK FAILED THE UNLOADED VOLTAGE CHECK, AND THE VOLTAGE RAPIDLY DECREASED UPON MEASUREMENT. IT ALSO FAILED TO UPLOAD ANY SIGNIFICANT VOLTAGE WHILE PLUGGED INTO AN AC POWER SOURCE, AND THE CORDS GREEN LED WAS NOT ON WHILE PLUGGED IN. THE COUNTER AND CHAT REPORT INFORMATION INDICATED THAT THE POWER BRICK'S FAILURE WAS AN OUT OF THE BOX FAILURE. THE POWER BRICK'S CASE TEMPERATURE BECAME EXCESSIVELY HOT AFTER TWENTY MINUTES; THIS WAS MEASURED FROM AN AREA ON TOP OF THE CASE ADJACENT TO WHERE THE CORD AND STRAIN RELIEF EXIT THE POWER BRICK. AFTER MEASUREMENTS WERE MADE, A KNOWN GOOD POWER BRICK WAS USED TO POWER ON THE COMMUNICATOR AND THE COMMUNICATOR PASSED ALL BASELINE CHECKS. THE DAMAGED POWER BRICK ALLEGATION WAS CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE INITIAL SET UP OF THIS LATITUDE COMMUNICATOR THE POWER CORD MADE A BUZZING NOISE AND THEN MELTED. NO ADVERSE PATIENT EFFECTS WERE NOTED. REQUESTS HAVE BEEN MADE FOR THE POWER CORD AND COMMUNICATOR TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMUNICATOR ACCESSORY LWS EXTERNAL MANUFACTURER 6476

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR H175| 4518| H170| N119| 4549| 4194| 0185| 4076