BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDITRACE CADENCE

    MDR report key: 3131166 · Received May 22, 2013

    Report

    Report Number
    MW5030286
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A CODE SITUATION. DEFIBRILLATOR PADS APPLIED AND A SHOCK WAS INITIATED. LIFEPAK20 DEFIBRILLATOR UTILIZED TO RESUSCITATE PT. A LOUD POP SOUND RESULTED IN NON-DELIVERANCE OF TREATMENT SHOCK - CLOSER INSPECTION REVEALED BREAK IN CABLE SYSTEM. LIFEPAK20 WAS CLEARED BY FACILITY BIOMED DEPARTMENT. NEW SET OF DEFIBRILLATION ELECTRODES APPLIED AND PT SUCCESSFULLY DEFIBRILLATED AND RESUSCITATED. CABLES HAVE AN ARC LOOKING DEFECT NEAR THE CONNECTION TO THE DEFIBRILLATOR. LEADS APPEAR TO BE CUT OFF AND UNABLE TO LOCATE LEAD OR PACKAGING. NO PACKAGING SAVED SO UNABLE TO DETERMINE LOT NUMBER, EXPIRATION DATE, ETC. DIFFERENT PACKAGE FROM SAME TYPE OF LEADS AVAILABLE. UNK IF FROM SAME LOT NUMBER, EXPIRATION DATE, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226522 MEDITRACE CADENCE ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODS MKJ COVIDIEN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention