BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3133111 · Received May 29, 2013

    Report

    Report Number
    3015876-2013-00440
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    May 1, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE USER INTERFACE PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THEN RETURNED THE DEVICE TO THE CUSTOMER. THE REMOVED USER INTERFACE PCB ASSEMBLY WAS FURTHER EVALUATED IN THE FAILURE ANALYSIS CENTER. IT WAS OBSERVED THAT AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U5 WAS ELECTRICALLY DAMAGED. THE ELECTRICALLY DAMAGED IC CHIP IS WAS CAUSED THE KEYPAD MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE SMALL KEYPAD ON THE DEVICE WAS MALFUNCTIONING. THE SMALL KEYPAD INCLUDES NON CRITICAL FUNCTIONS ON THE DEVICE. AFTER FURTHER EVALUATION, IT WAS OBSERVED BY PHYSIO-CONTROL THAT SOME CRITICAL BUTTONS ON THE MAIN KEYPAD ASSEMBLY (ON, SHOCK, CHARGE, ETC) WERE ALSO NOT FUNCTIONAL. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237562 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1