BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 3233146 · Received July 18, 2013

    Report

    Report Number
    3015876-2013-00632
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED POWER SUPPLY ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND OBSERVED THAT ONLY AC POWER WAS FAILING AND THE ASSEMBLY WOULD NOT CHARGE A BATTERY. DC (BATTERY) POWER DID OPERATE PROPERLY WHEN A CHARGED BATTERY WAS INSTALLED. IT WAS DETERMINED THAT THE CAUSE OF THE NO AC OPERATION AND NO BATTERY CHARGE WAS DUE TO A SHORTED FIELD EFFECT TRANSISTOR (FET), DESIGNATOR Q6, ON THE EOS POWER SUPPLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON WITH AC OR DC (BATTERY) POWER. THE FAILURE WAS OBSERVED DURING A SHIFT CHECK, SO THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336211 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1