BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMUNICATOR

    MDR report key: 1853630 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14971
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 21, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMMUNICATOR WAS RETURNED FOR ANALYSIS. THE POST MARKET QUALITY ASSURANCE LAB CONFIRMED THAT THE POWER SUPPLY BECAME HOT TO THE TOUCH DURING ANALYSIS, AND THE POWER BRICK CASE WAS FOUND TO BE MELTED. THE NO DIAL TONE ALLEGATION WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR DISPLAYED NO DIAL TONE DURING SETUP. DURING TROUBLESHOOTING, THE PATIENT ADVOCATE REPORTED THAT THE POWER SUPPLY WAS HOT TO THE TOUCH. NO PATIENT INJURY WAS REPORTED. A REPLACEMENT COMMUNICATOR WAS SHIPPED TO THE PATIENT. SETTING UP COMM GETTING NDT. SETTING UP IN BEDROOM. (B)(6). PHONE MAN PUT SOMETHING IN THE WALL AND IT HANGS OUT FROM THE JACK. HAD MRS VERIFY IF IS (B)(6) FILTER. SOUNDS LIKE A (B)(6) FILTER BUT PT DOESN'T KNOW FOR SURE. NO LONGER HAS GREEN POWER LIGHT. COMM PLUGGED INTO POWER STRIP. VERIFIED COMM PLUGGED IN ON BACK SIDE OF COMM. SUGGESTED UNPLUGGING COMM TO TRY MOVING TO ANOTHER ELECTRICAL OUTLET. MRS SAID WHEN SHE TOUCHED THE POWER BRICK IT WAS SO HOT TO THE TOUCH SHE COULDN'T UNPLUG IT. LRL NOT AVAILABLE TODAY. ADVISED MRS TO UNPLUG THE POWER STRIP FROM THE WALL. ADVISED MRS TO LEAVE STRIP UNPLUGGED UNTIL THE POWER BRICK IS NO LONGER HOT AND THEN UNPLUG THE POWER BRICK AND WILL THEN BE ABLE TO PLUG HER POWER STRIP INTO THE ELECTRICAL OUTLET. ADVISE LEAVE COMM UNPLUGGED UNTIL WE (LRL) CALLS HER BACK ON MONDAY 6.29. VERIFIED PHONE # IS CORRECT, (B)(6).

    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 77 YR 4555| 4136| N119| 0185