BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2021987 · Received March 10, 2011

    Report

    Report Number
    3015876-2011-00227
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED AN INTERMITTENT FAILURE TO BOOT UP NORMALLY, A LOCK UP ISSUE. PHYSIO DETERMINED THE CAUSE OF THE MALFUNCTION TO BE A FAILED SINGLE BOARD COMPUTER (SBC) FROM THE SYSTEM PCB ASSEMBLY. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOCKED UP AS THE CUSTOMER TRIED TO POWER IT ON DURING A PATIENT CALL. HOWEVER, NORMAL DEVICE OPERATION WAS RESTORED AFTER THE USER REMOVED AND REINSTALLED THE BATTERIES. THERE WAS NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE DEVICE USE. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT 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