BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 2949248 · Received February 7, 2013

    Report

    Report Number
    2124215-2013-02669
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 20, 2012
    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 ALLEGATION AGAINST THIS COMMUNICATOR WAS CONFIRMED. ELECTRICAL OVERSTRESS (EOS) WAS THE CAUSE OF THE COMMUNICATOR'S FAILURE AND A COMPONENT OF THE INTERNAL MODEM CIRCUITRY WAS FOUND TO BE BURNT. THE PLACARD WAS NEVER REMOVED FROM THIS UNIT AND UPON REMOVAL OF THE BACK COVER, A BUG INFESTATION WAS OBSERVED ON THE PLACARD. DUE TO THE EOS DAMAGE, NO PARTS WILL BE CHANGED AND NO FURTHER ANALYSIS BE PERFORMED ON THIS COMMUNICATOR.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS COMMUNICATOR DISPLAYED NO DIAL TONE (NDT). TROUBLESHOOTING THE ISSUE WAS UNSUCCESSFUL. A RECENT STORM AND/OR POWER OUTAGE HAPPENED ABOUT TWO WEEKS AGO, WHICH WAS THE SAME TIME THAT THE NDT ISSUE STARTED OCCURRING. THE COMMUNICATOR WILL BE TAKEN OUT-OF-SERVICE AND RETURNED DUE TO POSSIBLE STORM DAMAGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52217 COMMUNICATOR ACCESSORY LWS EXTERNAL MANUFACTURER 6476

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 1861| E110| 4473| 0154