BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL ONE STEP PACING CABLE

    MDR report key: 2978439 · Received February 19, 2013

    Report

    Report Number
    MW5029070
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ZOLL MEDICAL
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WE HAVE HAD MULTIPLE OUTSIDE INSULATOR ISSUES WITH ZOLL PART NUMBER 1009-0913-02 ONE STEP CABLES IN THE LAST 60 DAYS. THE OUTSIDE JACKET IS CRACKING COMPLETELY IN HALF AND PULLING AWAY FROM THE STRAIN RELIEF AFTER ONLY ABOUT 3 YEARS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72448 ZOLL ONE STEP PACING CABLE TRANSTHORACIC PACING CABLE MLN ZOLL MEDICAL 1009-0913-02

    Patients

    Seq Age Sex Outcome Treatment
    1