BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAC 1200 GENERIC LEAD WIRES

    MDR report key: 1188455 · Received September 29, 2008

    Report

    Report Number
    1651104-2008-00004
    Event Type
    Other
    Date Received
    September 29, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 29, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    DPS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO GE HEALTHCARE FOR EVALUATION. THE EVENT OCCURRED SINCE THE USER PLUGGED LEAD WIRES INTO INCORRECT SOCKETS OF THE PATIENT ACQUISITION MODULE. STEPS ARE BEING TAKEN TO PREVENT MISUSE OF THE LEADWIRES, BY INCLUDING A WARNING STATEMENT IN THE INSTRUCTIONS FOR USE FOR FUTURE LEADWIRES. THIS WARNING STATEMENT IS ALREADY PRESENT IN ALL OF THE MAC USER MANUALS. FOLLOWING WARNING STATEMENT IS DISPLAYED IN MANUALS: "CAUTION. TRACE EACH INDIVIDUAL LEADWIRE FROM ITS COLORED ID'ED CONNECTOR BACK TO THE ACQUISITION MODULE LABEL TO INSURE THAT IT IS MATCHED TO THE CORRECT LABEL LOCATION. IMPROPER CONNECTION WILL CAUSE INACCURACIES IN THE ECG."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT IS POSSIBLE TO TRANSPOSE ECG LEAD WIRES ON THE MAC 1200 SYSTEM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAC 1200 GENERIC LEAD WIRES NON INVASIVE CARDIOLOGY DEVICES DPS GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1