BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 2854687 · Received December 3, 2012

    Report

    Report Number
    3015876-2012-00869
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE THE GROUND SECTION OF AN INDUCTOR, DESIGNATOR L1 FROM THE ANALOG PCB ASSEMBLY WHICH CAUSED 79.4 MA OF CURRENT DRAW WHICH DEPLETED THE BATTERY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER A REPLACEMENT DEFIBRILLATOR. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED EVENT 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

    IT WAS REPORTED THAT THE DEVICE HAD THE SERVICE WRENCH ILLUMINATED AND DEPLETED A NEW FULLY CHARGED BATTERY IN LESS THAN A COUPLE OF DAYS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1