BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3213976 · Received July 9, 2013

    Report

    Report Number
    3015876-2013-00596
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 17, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED THAT THE EVENT CODES IN THE DEVICE'S MEMORY TRIGGERED THE SERVICE WRENCH AND THAT THE UNIT WOULD NOT CHARGE OR SHOCK WHEN PROMPTED. THERE WERE ALSO NO VOICE PROMPTS. THE CAUSE OF THE REPORTED FAILURE WAS THE DIGITAL PCB ASSEMBLY. COMPONENT LEVEL CAUSE COULD NOT BE DETERMINED. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE WRENCH PRESENT ON THE DISPLAY AND NO VOICE PROMPTS. UPON EXAMINATION OF THE DEVICE, PHYSIO OBSERVED THAT THE UNIT HAD NUMEROUS EVENT CODES LOGGED IN THE MEMORY AND THAT THE UNIT WOULD NOT CHARGE OR SHOCK, WHEN PROMPTED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314127 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1