BEUDAMED
    FDA Adverse Event Other Summary report: N

    CADENCE PHYSIO QC ADULT

    MDR report key: 3338520 · Received September 6, 2013

    Report

    Report Number
    1219103-2013-00047
    Event Type
    Other
    Date Received
    September 6, 2013
    Date of Event
    May 2, 2013
    Report Date
    August 8, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATOR ELECTRODES. THE CUSTOMER STATES THAT A (B)(6) MALE WAS UNRESPONSIVE AND HAD A HEART RATE OF 26. WHILE TRYING TO PACE THE PATIENT, THERE WAS NO VISIBLE RHYTHM ON THE LIFE PACK. THE DEFIBRILLATOR WAS CHANGED THREE TIMES, INCLUDING TRYING TO USE THE EMS CREW'S DEFIBRILLATOR AND THE SAME COVIDIEN DEFIB/PACING PADS, WITH COVIDIEN EKG LEADS WHILE CHANGING THE MONITOR. ALL SETS OF WIRE WERE CHANGED MULTIPLE TIMES. THE CUSTOMER ADVISED THEY EVENTUALLY THOUGHT TO CHANGE THE COVIDIEN PADS, BY WHICH THEY WERE FINALLY ABLE TO VIEW A RHYTHM ON THE LIFE PACK AND SUBSEQUENTLY PACE THE PATIENT. THE EMERGENCY ROOM EDUCATOR WAS ALSO AT THE BEDSIDE AND MULTIPLE NURSES DOUBLE CHECKED THE PLACEMENT OF DEFIB/PACING PADS AND THREE LEADS FOR PROPER PACING CONFIGURATION. CPR WAS EVENTUALLY REQUIRED TO GET A PERFUSING RHYTHM. THE PATIENT EXPIRED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444684 CADENCE PHYSIO QC ADULT DEFIBRILLATOR ELECTRODES MLN COVIDIEN 22550A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other