BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE MAC 5000

    MDR report key: 488452 · Received September 16, 2003

    Report

    Report Number
    MW1029604
    Event Type
    Injury
    Date Received
    September 16, 2003
    Date of Event
    August 11, 2003
    Report Date
    September 16, 2003
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GE MAC 5000 EKG MACHINE IN THE EMERGENCY DEPT WAS FOUND TO HAVE THE LEADS REVERSED AT THE ACQUISITION MODULE OF THE MACHINE. THIS CAUSED AN ERRONEOUS TRACING AND CONTRIBUTED TO THE DECISION TO PROCEED WITH CARDIAC CATHETERIZATIION. THERE WAS NO SAFETY PROVISION IN PLACE TO PROHIBIT REVERSAL OF THE LEAD WIRES OR ALERT THE USER THAT THE WIRES WERE REVERSED. THE LEAD WIRES ARE EASILY REMOVEABLE FROM THE ACQUISITION MODULE AND ABLE TO BE REINSERTED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE MAC 5000 12 LEAD EKG MACHINE DPS GENERAL ELECTRIC CO. PN2000657-033 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization