BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2851711 · Received November 29, 2012

    Report

    Report Number
    3015876-2012-00863
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE EVENT RECORD DOWNLOAD AND VERIFIED THE REPORTED DEVICE RESET, POWERING OFF AND ON, FOR FOUR MINUTES. HOWEVER, PHYSIO WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM DURING TESTING. PHYSIO DETERMINED THE CAUSE FOR THE ISSUE TO BE THE SYSTEM/ MEMORY PCB ASSEMBLY AND REPLACED IT. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE RETURNED TO THE CUSTOMER FOR USE. ADDITIONAL EVALUATION OF THE REMOVED SYSTEM/MEMORY PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER WAS UNABLE TO DETERMINE FURTHER CAUSE FOR THE ISSUE.

    Description of Event or Problem · 1

    DURING MONITORING OF A PATIENT TRANSPORT TO THE HOSPITAL, IT WAS REPORTED THAT THE DEVICE PRINTED TWO FEET OF BLANK PAPER AND REBOOTED (POWERED OFF AND ON) MULTIPLE TIMES. THE DEVICE ISSUE HAD NO ADVERSE EFFECTS ON THE PATIENT OUTCOME. 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(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR