BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1328647 · Received February 25, 2009

    Report

    Report Number
    3015876-2009-00216
    Event Type
    Death
    Date Received
    February 25, 2009
    Date of Event
    January 28, 2009
    Report Date
    January 28, 2009
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER STATED THE DEVICE DID NOT MALFUNCTION, THAT THE EVENT WAS DUE TO A USER ERROR, THAT THE AC CORD WAS NOT FULLY PLUGGED INTO AC POWER AND THE BATTERY HAD NOT BEEN CHARGING. IT IS UNKNOWN IF THE USER RE-CONNECTED THE DEVICE TO AC POWER DURING THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE REPORTER SAID THE DEVICE WAS USED IN BATTERY POWER TO ATTEND TO A PATIENT IN CARDIAC ARREST. ACCORDING TO THE REPORTER, THE DEVICE FAILED TO DELIVER ENERGY TO THE PATIENT AND THEN POWERED OFF BY ITSELF. THE REPORTER STATED THAT WHEN THE USER WENT TO OBTAIN ANOTHER DEVICE, THE PATIENT HAD EXPIRED.

    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 UNK Death