BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2852931 · Received November 30, 2012

    Report

    Report Number
    3015876-2012-00864
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO REPLACED THE THERAPY PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.THE REMOVED THERAPY PCB ASSEMBLY WAS FURTHER EVALUATED IN THE FAILURE ANALYSIS CENTER. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE DUE TO A FAILURE OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U5. THE INTEGRATED CIRCUIT CHIP WAS REPORTEDLY DAMAGED HOWEVER, IT IS UNKNOWN WHAT DAMAGED OCCURRED TO THE CHIP TO CAUSE THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD NO LONGER POWER ON. THE CUSTOMER ADVISED THAT THEY HAVE TRIED A DIFFERENT BATTERY AND POWER SOURCE AND THE DEVICE STILL IS UNABLE TO POWER ON. 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