BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAC 500 / 1200 GENERIC LEAD WIRES

    MDR report key: 1059610 · Received June 10, 2008

    Report

    Report Number
    1651104-2008-00003
    Event Type
    Other
    Date Received
    June 10, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 10, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    DPS
    PMA / PMN Number
    K042177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED DUE TO THE FAILURE TO FOLLOW CLINICALLY PRESCRIBED PROCEDURE WHICH INCLUDES TRACING EACH INDIVIDUAL LEADWIRE FROM ITS COLORED IDENTIFIED CONNECTOR BACK TO THE ACQUISITION MODULE LABEL TO INSURE THAT IT IS MATCHED TO THE CORRECT LABEL LOCATION. INSTRUCTIONS FOR USE WERE REVIEWED FOR BOTH THE ECG DEVICES AND THE LEADWIRES. THE ECG DEVICE INSTRUCTIONS CONTAINS THE FOLLOWING WARNING STATEMENT: "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." THE LEADWIRE INSTRUCTIONS FOR USE WILL BE MODIFIED TO INCLUDE THE SAME STATEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SOCKET CONNECTORS IN THE MAC 1200 10 LEAD TRUNK CABLE MAKE IT POSSIBLE FOR THE USER TO INCORRECTLY PUT THE CHEST AND LIMB LEADS IN THE WRONG SIDE OF THE TRUNK CABLE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAC 500 / 1200 GENERIC LEAD WIRES NON-INVASIVE CARDIOLOGY DEVICES DPS GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1