BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2091403 · Received May 5, 2011

    Report

    Report Number
    3015876-2011-00368
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE PROGRAMMED SYSTEM CONTROLLER PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED SYSTEM CONTROLLER PCB ASSEMBLY AND OBSERVED AND INTERMITTENT LOCK UP FAILURE. THE CAUSE OF THE MALFUNCTION WAS DETERMINED TO BE THE U61 IC CHIP.

    Description of Event or Problem · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT IT LOCKED UP DURING A BOOT UP. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA