BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX TC CABLE

    MDR report key: 307249 · Received November 27, 2000

    Report

    Report Number
    2126677-2000-00017
    Event Type
    Malfunction
    Date Received
    November 27, 2000
    Date of Event
    October 20, 2000
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GEMS THAT DURING A MANUFACTURING REVIEW OF THE VENDOR-PRODUCED CABLE 2141977, USED IN ADVANTX TC VASCULAR SYSTEMS (I.E., FOR IDF OPTION), A PRODUCTION ERROR INVOLVING INSULATION ALLOWS THE SCREW FROM THE CONNECTOR ATTACHMENT CLAMP TO COME INTO CONTACT WITH ONE OF THE PHASE LEADS OF THE CABLE RESULTING IN AN ELECTRICAL SHOCK HAZARD. CORRECTIVE ACTIONS AT BOTH THE VENDOR AND AT GE HAVE BEEN IMPLEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTX TC CABLE DIAGNOSTICS X-RAY IZI GE MEDICAL SYSTEMS 2141977 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA