BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1021915 · Received March 28, 2008

    Report

    Report Number
    3015876-2008-00236
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    October 11, 2007
    Report Date
    February 28, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP EVALUATED THE DEVICE. PROPER OPERATION WAS OBSERVED DURING FUNCTIONAL AND PERFORMANCE TESTING. THE REPORTED PROBLEM WAS NOT DUPLICATED. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS NOT DETERMINED. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PARAMEDICS USED THE DEVICE TO ADMINISTER A SHOCK TO A PATIENT DIAGNOSED IN CARDIAC ARREST. WHEN THE DEFIBRILLATOR WAS CHARGED TO ADMINISTER A SECOND SHOCK, THE DEVICE REPORTEDLY SHUT OFF. THE OPERATOR TURNED THE DEVICE BACK ON AND WHEN THE DEFIBRILLATOR WAS CHARGED TO ADMINISTER A SECOND SHOCK, THE DEVICE AGAIN REPORTEDLY SHUT OFF. THE BATTERIES IN THE DEVICE WERE CHANGED AND THEY SUBSEQUENTLY FUNCTIONED PROPERLY AND A SHOCK WAS ADMINISTERED TO THE PATIENT. THE PATIENT'S OUTCOME WAS NOT REPORTED. THERE WERE NO REPORTS OF ADVERSE AFFECTS TO THE PATIENT REPORTED AS A RESULT OF DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK