BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE MAC 5500

    MDR report key: 1075392 · Received July 11, 2008

    Report

    Report Number
    MW5007614
    Event Type
    Other
    Date Received
    July 11, 2008
    Date of Event
    April 29, 2008
    Report Date
    July 11, 2008
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    DPS
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WE BECAME AWARE OF SOME INTERFERENCE WITH THE DIAGNOSTIC ACCURACY OF ELECTROCARDIOGRAMS PERFORMED IN THE EMERGENCY DEPT, OVER THE TIME PERIOD OF 5 DAYS: 2008. UPON REVIEW OF THE EKGS BY AN INDEPENDENT CARDIOLOGIST, THE FOLLOWING ISSUES WERE IDENTIFIED: THE LEAD WIRES WERE MISCONNECTED TO THE ACQUISITION MODULE OF THE MAC CART; THE NON-LABELED FEATURE OF THE PROXIMAL END OF THE LEAD WIRES CONTRIBUTED TO THE MISCONNECTION OF THE LEAD WIRES; THE DEVICE SOFTWARE WAS INCONSISTENT IN GIVING ERROR MESSAGES OF SUSPECTED LIMB LEAD REVERSAL ON THE EKG TRACING. IN LIGHT OF THE FACT THAT THERE IS NO VISIBLE LABELING ON THE PROXIMAL ENDS OF THE LEAD WIRES CONNECTED TO THE ACQUISITION MODULE OF THE MAC CART, THE POSSIBLE MISCONNECTION OF A LEAD WIRE IS NOT EASILY DETECTABLE BY A USER. AS, IN SOME CIRCUMSTANCES, AN EKG IS A DEFINITIVE TEST, POTENTIAL ADVERSE EVENTS - E.G., HOSPITALIZATION, INTERVENTION, INAPPROPRIATE DISCHARGE- COULD OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE MAC 5500 10 LEAD EKG CART DPS GENERAL ELECTRIC MAC 5500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other