BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1845342 · Received September 23, 2010

    Report

    Report Number
    3015876-2010-01051
    Event Type
    Death
    Date Received
    September 23, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 26, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE INTERNAL HLC BATTERY WAS DEPLETED AND THE CHARGE PAK INSTALLED IN THE DEVICE WAS THE ORIGINAL CHARGE PAK SHIPPED WITH THE DEVICE. THE CHARGE PAK WAS LABELED WITH AN EXPIRATION DATE OF 2006-12-28 (ELECTRODE EXPIRATION DATE). THE ELECTRODES FOUND WITH THE DEVICE ALSO HAD AN EXPIRATION DATE OF 2006-12-28. PHYSIO-CONTROL CHARGED THE HLC BATTERY FOR 10 DAYS WITH ANOTHER CHARGE PAK. ALSO, NEWER DEVICE SOFTWARE WAS INSTALLED. AFTERWARDS, PROPER OPERATIONS WAS CONFIRMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER WITH A NEW CHARGE PAK AND ELECTRODES. ADDITIONALLY, PHYSIO-CONTROL PROVIDED THE CUSTOMER WITH INFORMATION REGARDING RECOMMENDATIONS FOR PROPER TESTING AND MAINTENANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS ONLY ABLE TO PROVIDE ONE SHOCK TO A PT AND THEN THE DEVICE LOST POWER. THE PT WAS NOT RESUSCITATED. NO ADDITIONAL DETAILS WERE AVAILABLE OR PROVIDED. THE PT EVENT RECORD FROM THE REPORTED EVENT WAS NO LONGER IN DEVICE MEMORY DUE TO BIOMED TESTING OF THE DEVICE FOLLOWING THE REPORTED EVENT. A CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT DEVICE USE MAY HAVE CONTRIBUTED TO THE PT'S OUTCOME, SINCE THE DEVICE LOST POWER AFTER ONE SHOCK. ALSO, THE USER FAILED TO MAINTAIN THE DEVICE PROPERLY, AS DESCRIBED IN THE RECORDS RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death