BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2822471 · Received November 7, 2012

    Report

    Report Number
    3015876-2012-00829
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE USER INTERFACE AND SYSTEM CONTROLLER PCB ASSEMBLIES AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED PCB ASSEMBLIES AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A THERMALLY SENSITIVE INTEGRATED CIRCUIT CHIP, DESIGNATOR U8 FROM THE USER INTERFACE PCB ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD REBOOT ON IT'S OWN WHEN PERFORMING THE USER TEST AND EVERY TIME THE DEVICE WAS POWERED ON. THE DEVICE ALSO LOGGED SEVERAL EVENT CODES. AFTER AN EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WAS REBOOTING DURING THE USER TEST, AND THE DEVICE KEYPAD WOULD FUNCTION INTERMITTENTLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1