BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1982394 · Received January 14, 2011

    Report

    Report Number
    3015876-2011-00046
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    August 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL REPLACED THE USER INTERFACE PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED USER INTERFACE PCB ASSEMBLY AND DETERMINED THE CAUSE OF MALFUNCTION TO BE A THERMALLY SENSITIVE IC CHIP, DESIGNATOR U8.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAY WAS DISTORTED AND THE SERVICE LIGHT ILLUMINATED AS THE CUSTOMER WAS TRYING TO USE IT DURING A CODE BLUE. ANOTHER DEFIBRILLATOR WAS MADE AVAILABLE FROM DOWN THE HALL AND USED TO TREAT THE PATIENT. THE DEVICE USED HAD NO ADVERSE EFFECTS ON THE PATIENT. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT PROVIDED. PHYSIO-CONTROL'S INITIAL DEVICE EVALUATION VERIFIED THE REPORTED PROBLEM AS THE DEVICE HAD DISPLAY ISSUES. HOWEVER, FURTHER INVESTIGATION IDENTIFIED A CRITICAL MALFUNCTION THAT RESULTED IN AN INTERMITTENT FAILURE TO BOOT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK