BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEWLETT PACKARD

    MDR report key: 339882 · Received June 28, 2001

    Report

    Report Number
    339882
    Event Type
    Death
    Date Received
    June 28, 2001
    Date of Event
    June 15, 2001
    Report Date
    June 25, 2001
    Manufacturer
    AGILENT TECHNOLOGIES
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT APPROX 4:20 AM A CODE CALL WAS RUN ON A PT WHO WAS LOCATED ON THE SKILLED NURSING FACILITY UNIT. THE PT HAS BEEN HOSPITALIZED FOR A HIP FRACTURE. DURING THE CODE A HEWLETT PACKARD CODEMASTER DEFIBRILLATOR WAS USED. THE CODE TEAM WAS NOT ABLE TO GET A SIGNAL ON THE PT DURING THE CODE. THE CODE WAS ULTIMATELY UNSUCCESSFUL AND THE PT DIED. THE HEWLETT PACKARD CODEMASTER IN QUESTION WAS TESTED THREE TIMES FOLLOWING THE CODE AND FOUND TO BE IN FULL WORKING ORDER. TEST RUN INCLUDED OUTPUT CHECKS ON THE DEFIBRILLATOR AS WELL AS ECG CHECKS OF THE CABLES WITH APPROPRIATE TEST MODULES. THE LEAD WIRES ATTACHED TO THE MACHINE WERE FRAYED ON THE OUTER LAYER OF INSULATION BUT THE SIGNAL WIRES WERE INTACT AND UNDAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29243 HEWLETT PACKARD CODEMASTER DEFIBRILLATOR LDD AGILENT TECHNOLOGIES M1772A *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death