BEUDAMED
    FDA Adverse Event Other Summary report: N

    EP-WORKMATE

    MDR report key: 1376471 · Received May 5, 2009

    Report

    Report Number
    2248049-2009-00005
    Event Type
    Other
    Date Received
    May 5, 2009
    Date of Event
    March 24, 2009
    Report Date
    May 4, 2009
    Manufacturer
    ST. JUDE MEDICAL - COOPER RUN EXECUTIVE PARK
    Product Code
    DQK
    PMA / PMN Number
    K994011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE COMPLAINT WAS VERIFIED. THE CAUSE OF THE TRANSFORMER SPARKING WAS IDENTIFIED AS A BROKEN SOLDER JOINT IN THE POWER SUPPLY CIRCUIT.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT THE ISOLATION TRANSFORMER HAD AN ELECTRICAL BURN SMELL. THE DEVICE WAS NOT BEING USED IN A PATIENT PROCEDURE AT THE TIME OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP-WORKMATE DQK, PROGRAMMABLE DIAGNOSTIC COMPUTER DQK ST. JUDE MEDICAL - COOPER RUN EXECUTIVE PARK 55-0003-0004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK