BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 4061703 · Received September 4, 2014

    Report

    Report Number
    3015876-2014-01038
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL RECOMMENDED THAT THE DEVICE BE REPAIRED; HOWEVER, DUE TO THE COSTS ASSOCIATED WITH THE REPAIR THE CUSTOMER DECLINED SERVICE AND REQUESTED THAT THE UNIT BE RETURNED TO THEM UNREPAIRED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    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-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO WAS ABLE TO GET THE DEVICE TO LOCKUP INTERMITTENTLY WHILE PERFORMING CERTAIN FUNCTIONS, INCLUDING CHARGING THE DEVICE IN ORDER TO DEFIBRILLATE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE TESTING THEIR DEVICE THE DISPLAY TURNED WHITE, FOLLOWED BY THE WORD SERVICE SPLASHED ON THE DISPLAY AND ALL THE KEYPAD LED'S WERE FLASHING ON AND OFF. DURING THIS TIME THE DEVICE WAS IN A LOCK UP CONDITION AND WOULD NOT BE AVAILABLE FOR DEFIBRILLATION, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542248 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1