BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIGATOR CLIP LEAD WIRE KIT

    MDR report key: 1981929 · Received January 10, 2011

    Report

    Report Number
    1981929
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    CAREFUSION
    Product Code
    GXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT FELL APART UPON USE IN THE STERILE FIELD. THIS IS APPROXIMATELY THE FOURTH TIME THIS HAS HAPPENED. A COMPANY REP. PICKED UP THE FIRST FAILED DEVICE AND A REPLACEMENT PRODUCT WAS SENT TO US. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLIGATOR CLIP LEAD WIRE KIT LEAD, NEURO GXY CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR