BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKMATE CPU

    MDR report key: 1785962 · Received July 30, 2010

    Report

    Report Number
    2184149-2010-00012
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    January 6, 2009
    Report Date
    January 6, 2009
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DQK
    PMA / PMN Number
    K092810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FUNCTIONAL TESTING OF THE RETURNED UNIT PRODUCED AN ERROR MESSAGE WHICH CONFIRMED THE CUSTOMER COMPLAINT. THE CUSTOMER WAS ISSUED A REPLACEMENT COMPUTER.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PACING DURING A PROCEDURE, A BEEP WAS HEARD AND THE EP WORKMATE SCREENS WENT BLANK. THE EP4 TOUCH SCREEN REMAINED ON. THE USER WAS UNABLE TO STOP PACING ON THE EP WORKMATE KEYBOARD AND UNABLE TO STOP PACING ON THE EP4 TOUCH SCREEN. THE SYSTEM WAS RESTARTED AND THE USER HIT BEGIN/REVIEW STUDY AND WAS THEN ABLE TO STOP PACING VIA THE KEYBOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKMATE CPU EP WORKMATE DQK ST. JUDE MEDICAL, AF DIVISION WM-CPU-WIN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK