BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 5099261 · Received September 23, 2015

    Report

    Report Number
    3015876-2015-01172
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    August 23, 2015
    Report Date
    September 23, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED LOCKUP ISSUE. PHYSIO THEN REPLACED THE SYSTEM PCB ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE REMOVED SYSTEM PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THE SINGLE BOARD COMPUTER (SBC) CARD LOCATED ON THE SYSTEM PCB ASSEMBLY. THE SBC CARD WAS NOT SEATED PROPERLY WHICH RESULTED IN THE DEVICE BECOMING LOCKED UP AND UNRESPONSIVE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT AND THE DISPLAY WAS BLANK. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL CONFIRMED THE REPORTED ISSUE, BUT ALSO OBSERVED THAT THE POWER LED WAS ALSO LIT AND THAT THE DEVICE WAS UNRESPONSIVE WHEN THE BUTTONS ON THE MAIN KEYPAD ASSEMBLY WERE PRESSED. THIS BEHAVIOR IS CONSISTENT WITH A DEVICE LOCKUP CONDITION THAT COULD DELAY OR PREVENT DEFIBRILLATION IF IT WERE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628639 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1