BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHYSIO CONTROL

    MDR report key: 113798 · Received August 11, 1997

    Report

    Report Number
    113798
    Event Type
    Death
    Date Received
    August 11, 1997
    Date of Event
    June 26, 1997
    Report Date
    July 11, 1997
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE CARING FOR PT IN NEED OF TRANSCUTANEOUS PACING, PACING PADS WERE PLACED AND PACER ACTIVATED. MACHINE FAILED TO DELIVER PACING ENERGY AND/OR CAPTURE AN ELECTRICAL RHYTHM FOR PT. DEVICE ADVISED ABOUT LEAD PLACEMENT WHICH WAS APPROPRIATE. PT SUBSEQUENTLY DIED DESPITE OTHERWISE AGGRESSIVE ACLS MGMT OF CASE. PT PACING CABLES WERE ACCIDENTALLY CUT AT HOSP BY STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO CONTROL MONITOR DEFIBRILLATOR/PACER LDD PHYSIO CONTROL LIFEPAK 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| O| R