BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1021591 · Received March 25, 2008

    Report

    Report Number
    3015876-2008-00215
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    February 24, 2008
    Report Date
    February 25, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE. PROPER OPERATION WAS OBSERVED DURING FUNCTIONAL AND PERFORMANCE TESTING. ERROR CODE A101 WAS LOGGED INTO DEVICE MEMORY AT THE TIME OF THE REPORTED EVENT. THE DEVICE REPAIR INSTRUCTIONS RECOMMENDS THE REPLACEMENT OF THE POWER SUPPLY WITH A NEWER REVISION OF THE POWER SUPPLY ASSEMBLY WHEN THERE IS AN INTERMITTENT OCCURRENCE OF THIS ERROR CODE. THE POWER SUPPLY WILL BE REPLACED AND THE DEVICE WILL BE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE HOSP STAFF WERE CALLED TO A SUSPECTED CARDIAC ARREST. THE DEVICE WAS UNPLUGGED FROM AC MAINS POWER AND SWITCHED ON. UPON REACHING THE PT THE STAFF MEMBER PRESSED THE CHARGE BUTTON, BUT THE DEFIBRILLATOR REPORTEDLY FAILED TO CHARGE. IT WAS NOTED THAT THE RED SERVICE LIGHT WAS ILLUMINATED ON THE FRONT PANEL. THE UNIT WAS SET TO ONE SIDE AND ANOTHER DEFIBRILLATOR WAS MADE AVAILABLE AND USED TO TREAT THE PT. THE PT WAS NOT RESUSCITATED. THE CUSTOMER REPORTED THAT THE PT'S OUTCOME WAS NOT A RESULT OF DEVICE USE.

    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 MONITOR| AC POWER ADAPTER FOR THE LIFEPAK 12 DEFIBRILLATOR/