BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 2171444 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09774
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 7, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A BURNED RESISTOR WAS CONFIRMED AS THE CAUSE OF THE NO DIAL TONE. THE OBSERVED DAMAGE WAS CONSISTENT WITH A HIGH-POWER ELECTRICAL OVERSTRESS EVENT. THERE WAS VISIBLE INDICATION OF ELECTRICAL OVERSTRESS IN THE MODEM CIRCUITRY. THE PHONE LINES WERE VISIBLY BURNED AND ELECTRICALLY OPEN. THE TOP SIDE OF THE INTEGRATED MAIN CONTROL BOARD WAS EXPOSED. NO EVIDENCE OF DAMAGE WAS VISIBLE IN THE MODEM CIRCUITRY. RESISTANCE READINGS OF THE CAPACITORS AND RESISTORS WERE MADE WHICH SHOWED THEM TO BE GOOD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS COMMUNICATOR WAS INDICATING NO DIAL TONE. THE PATIENT REMOVED THE DSL FILER AND THE COMMUNICATOR WAS PLACED IN A DIFFERENT ROOM. NO DIAL TONE WAS STILL INDICATED. THE POWER CORD WAS REPLACED. AFTER THE POWER CORD WAS REPLACED, THE COMMUNICATOR STILL INDICATED NO DIAL TONE. AS A RESULT, THE COMMUNICATOR WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    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 71 YR 6947| T125| E110| 5076