BEUDAMED
    FDA Adverse Event Death Summary report: N

    1310P MEDITRACE 2/PK 20/CA

    MDR report key: 1882408 · Received October 21, 2010

    Report

    Report Number
    9681860-2010-00011
    Event Type
    Death
    Date Received
    October 21, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    COVIDIEN
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. THE MANUFACTURER OF THE LIFEPAK 12 WAS NOTIFIED BY THE CUSTOMER ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A PAIR OF THE MEDITRACE DEFIBRILLATOR PADS. THE CUSTOMER WAS CALLED TO A 911 CALL FOR A PT IN CARDIAC ARREST AT HER HOME. THE CUSTOMER STATED THAT THEY APPLIED THE DEFIBRILLATOR PADS ON THE PT UPON ARRIVAL. THE MEDIC TURNED ON THE LIFEPAK 12 DEFIBRILLATOR DEVICE. THE DEVICE TURNED ON AND THE STATS ON THE SCREEN STATED "NO LEADS FOUND" AND THE SERVICE LIGHT ON THE UNIT TURNED ON. THE MEDIC TOOK THE BATTERIES OUT OF THE LIFEPAK 12 UNIT AND REINSERTED. AFTER REINSERTING THE BATTERIES BACK INTO THE UNIT, THE MEDIC AGAIN TURNED ON THE UNIT AND THE SAME STATS APPEARED ON THE SCREEN. THE MEDIC AGAIN TOOK THE BATTERIES OUT AND REINSERTED THE BATTERIES AGAIN, THE MEDIC REPORTED THAT HE ATTACHED THE PT TO A 4 LEAD SYSTEM. THE MEDIC REPORTED AT THIS TIME THE PT WAS ASYSTOLE, AND THAT HE ADMINISTERED CARE FOR 15 MINS. THE MEDIC STATED AT THIS TIME THE PT WAS EXPIRED. THE MEDICS DID NOT REMOVE THE PT FROM THE SCENE BUT DID LEAVE THE PT IN THE CARE OF THE LOCAL POLICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1310P MEDITRACE 2/PK 20/CA DEFIB PADS DRX COVIDIEN 31319281 928703

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death