BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAC 1200 UNIVERSAL LEADWIRE

    MDR report key: 1290942 · Received December 11, 2008

    Report

    Report Number
    1651104-2008-00005
    Event Type
    Other
    Date Received
    December 11, 2008
    Date of Event
    November 11, 2008
    Report Date
    December 11, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    DPS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A: UNDER EUROPEAN PT LAWS & REGULATIONS, PT INFO IS CONSIDERED STRICTLY CONFIDENTIAL AND WILL NOT BE DISCLOSED BY THE HOSPITAL. THE DEVICE WAS NOT RETURNED TO GE HEALTHCARE FOR EVALUATION. THE EVENT OCCURRED SINCE THE USER PLUGGED LEAD WIRES INTO INCORRECT SOCKETS OF THE PT 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. THE FOLLOWING WARNING STATEMENT IS DISPLAYED IN NEW INSTRUCTIONS FOR USE INCLUDED WITH LEADWIRES: "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 THE 2 BLOCKS OF 5 PT ECG LEADS HAD BEEN INTERCHANGED. THE RESULTING ECG WAS GOOD, BUT SHOWED THE PT HAD AN MI AND WAS ABOUT TO BE TREATED FOR A HEART ATTACK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAC 1200 UNIVERSAL LEADWIRE NON INVASIVE CARDIOLOGY ACCESSORIES DPS GE HEALTHCARE 22341808

    Patients

    Seq Age Sex Outcome Treatment
    1