BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3823151 · Received May 21, 2014

    Report

    Report Number
    3015876-2014-00579
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 25, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).FOLLOW-UP INFORMATION:PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE. IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN OPEN INDUCTOR, DESIGNATOR L1, LEG 1 TO LEG 4, ON THE ANALOG PCB ASSEMBLY

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE DEVICE WAS TESTED WITH SEVERAL BATTERIES, BUT COULD NOT BE POWERED ON. IT WAS OBSERVED THAT THE DEVICE SHOWED A SERVICE WRENCH ICON AND EMPTY BATTERY INDICATOR IN THE READINESS DISPLAY. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE 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

    THE CUSTOMER REPORTED TO A PHYSIO-CONTROL SERVICE REPRESENTATIVE THAT THEIR DEVICE COULD NOT BE POWERED ON. THEY TRIED AGAIN AFTER HAVING REPLACED THE BATTERY, BUT THE DEVICE COULD NOT BE POWERED ON. THERE WAS NO PATIENT USE ASSOCIATION REPORTED WITH THE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303817 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1