BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3033691 · Received April 3, 2013

    Report

    Report Number
    3015876-2013-00267
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE THIRD PARTY BIOMED EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE DEVICE HAS BEEN REMOVED FROM SERVICE AND CURRENTLY AWAITING DECISIONS ON THE NEXT STEPS. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS. THEREFORE, THE CAUSE FOR THE REPORTED PROBLEM COULD NOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO CHARGE ENERGY DURING A PATIENT EVENT. THE DEVICE WAS IN USE TO TREAT (B)(6) MALE IN ELECTROPHYSIOLOGY LABORATORY. THE PATIENT WENT INTO VT RHYTHM AND THE USER APPLIED ELECTRODES AND ATTEMPTED TO CHARGE ENERGY BUT THE DEVICE FAILED TO CHARGE AND REBOOTED. THE PATIENT HAD A FUNCTIONING INTERNAL DEFIBRILLATOR AND A BACKUP LIFEPAK 12 DEFIBRILLATOR WAS AVAILABLE FOR USE. IT IS UNKNOWN IF THE OPERATOR USED THE BACKUP OPTIONS TO PROVIDE CARE. THE DEVICE WAS IN USE WITH AC POWER AND HAD CHARGED BATTERIES. THE PATIENT SURVIVED THE EVENT. THERE WAS NO ADVERSE OUTCOME DUE TO THE DEVICE USE. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135675 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR