BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2872956 · Received December 13, 2012

    Report

    Report Number
    3015876-2012-00899
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED INTERMITTENT FAILURE. THE USER INTERFACE AND SYSTEM CONTROLLER PCB ASSEMBLIES WERE REPLACED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. THE REMOVED PCB ASSEMBLIES WERE FURTHER EVALUATED AND THE CAUSE OF THE REPORTED INTERMITTENT FAILURE WAS DETERMINED TO BE THE KEYPAD DOMES LOCATED ON THE USER INTERFACE PCB ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD INTERMITTENTLY FAIL TO DELIVER DEFIBRILLATION ENERGY. 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