BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX VASCULAR SYSTEM CABLE

    MDR report key: 339612 · Received January 5, 2001

    Report

    Report Number
    6000088-2001-00004
    Event Type
    Malfunction
    Date Received
    January 5, 2001
    Date of Event
    October 20, 2000
    Report Date
    January 5, 2001
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    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 2141260, USED IN ADVANTX 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
    870 ADVANTX VASCULAR SYSTEM CABLE DIAGNOSTIC X-RAY IZI GE MEDICAL SYSTEMS EUROPE 2141260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA