BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1030763 · Received April 17, 2008

    Report

    Report Number
    3015876-2008-00349
    Event Type
    Death
    Date Received
    April 17, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 18, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED INCIDENT.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CODE THE DEVICE WOULD TURN ON, BUT IT WAS INOPERABLE. ALL THE CONTROLS WERE UNRESPONSIVE. THE PATIENT WAS NOT RESUSCITATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CODE THE DEVICE WOULD TURN ON, BUT IT WAS INOPERABLE. ALL THE CONTROLS WERE UNRESPONSIVE. THE PATIENT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Death