BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMMUNICATOR

    MDR report key: 2052587 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03458
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    August 8, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING PRODUCT RETURN AND ANALYSIS. THIS SECTION WILL BE UPDATED UPON COMPLETION OF THE LAB ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE POWER BRICK WAS DEFORMED FROM HEAT AND A BURNING SMELL WAS NOTED. THE POWER BRICK FAILED TO OUTPUT ANY SIGNIFICANT VOLTAGE WHILE PLUGGED INTO A POWER SOURCE. THE POWER BRICK'S CASE TEMPERATURE REACHED 109.1 DEGREES C. AFTER 25 MINUTES.

    Additional Manufacturer Narrative · 1

    THE POWER SUPPLY IS BEING ANALYZED BY BSC CRM POST MARKET QUALITY ASSURANCE LABORATORY. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE POWER SUPPLY FOR THIS COMMUNICATOR WAS HOT TO THE TOUCH. THE PATIENT REPORTED THAT HE DID NOT RECEIVE A THIRD DEGREE BURN BUT THE POWER SUPPLY WAS VERY HOT THE TOUCH. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. THE COMMUNICATOR AND POWER SUPPLY WERE REPLACED. THE POWER SUPPLY WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE POWER CORD TO THIS COMMUNICATOR WAS HOT TO THE TOUCH AND BURNED THE PATIENT. AS A RESULT, THE COMMUNICATOR AND POWER CORD WERE REPLACED.

    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 64 YR Other T177| E102| 0184