BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 1872192 · Received October 12, 2010

    Report

    Report Number
    3015876-2010-01112
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    June 23, 2010
    Report Date
    September 14, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED AN INTERMITTENT BOOT UP FAILURE PHYSIO DETERMINED THE CAUSE OF THE PROBLEM TO BE A FAILURE OF A TEMPERATURE SENSITIVE IC CHIP, DESIGNATOR U16, FROM THE SINGLE BOARD COMPUTER (SBC) ASSEMBLY ON THE SYSTEM PCB ASSEMBLY. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING THE DEVICE USE TO MONITOR A PT ON THE WAY TO HOSPITAL, THE DEVICE WAS REPORTED TO HAVE A BLACK SCREEN AND ILLUMINATE THE SERVICE INDICATOR. THE USER POWER CYCLED THE DEVICE AND NORMAL OPERATION WAS RESTORED. HOWEVER, THE ISSUE RECURRED INTERMITTENTLY DURING THE PT TRANSPORT AND THE DEVICE LOGGED MULTIPLE EVENT CODES IN THE MEMORY. THE DEVICE USE HAD NO ADVERSE EFFECTS ON THE PT. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 15 MONITOR/DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK