BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3875170 · Received June 16, 2014

    Report

    Report Number
    3015876-2014-00657
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED SYSTEM PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED DEVICE FAILURE WAS A FAILURE OF THE SINGLE BOARD COMPUTER (SBC). THE SBC IS LOCATED ON THE SYSTEM PCB ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO POWER THEIR DEVICE ON, IT WOULD CYCLE POWER AND NOT COMPLETE ITS BOOT UP CYCLE. THE DEVICE COULD NOT BE USED ON A PATIENT, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352012 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1