BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEWLETT - PACKARD

    MDR report key: 430593 · Received November 27, 2002

    Report

    Report Number
    430593
    Event Type
    Injury
    Date Received
    November 27, 2002
    Date of Event
    November 15, 2002
    Report Date
    November 25, 2002
    Manufacturer
    PHILLIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DEFIBRILLATOR WAS SUCCESSFULLY USED ON THE PATIENT AT 200 JOULES AND 300 JOULES BUT FAILED TO CHARGE AT 360 JOULES. A SECOND DEFIBRILLATOR UNIT AT BEDSIDE WAS USED TO CONTINUE DEFIBRILLATION.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/17/03: THE COMPLAINANT REPORTED THAT A PT WAS IN COMPLETE HEART BLOCK WHEN THEY ARRIVED AT THE HOSPITAL'S EMERGENCY DEPARTMENT. EMERGENCY DEPARTMENT STAFF DEFIBRILLATED THE PT AT 200 JOULES AND 300 JOULES. THEY THEN ATTEMPTED TO DELIVER 360 JOULES TO THE PT. THE DEFIBRILLATOR CHARGED TO 352 JOULES, BUT THEN DUMPED ITS CHARGE INTERNALLY. THE DEFIBRILLATOR DISPLAYED A "DISARMED" MESSAGE FOLLOWED BY "ERROR 2". THEY WERE UNABLE TO RESUSCITATE THE PT AND THE PT SUBSEQUENTLY EXPIRED. THE DEVICE WAS EVALUATED BY THE HOSPITAL'S BIOMEDICAL ENGINEERING DEPARTMENT AND THE ALLEGED PROBLEM WAS CONFIRMED. THE SUBJECT DEFIBRILLATOR'S POWER SUPPLY WAS SWAPPED WITH A POWER SUPPLY FROM A WORKING DEFIBRILLATOR. THE SUBJECT DEFIBRILLATOR WAS RESTORED TO FULL FUNCTIONALITY. NEITHER THE SUBJECT DEFIBRILLATOR NOR THE POWER SUPPLY HAS BEEN RETURNED TO PHILIPS FOR FAILURE ANALYSIS AND, THEREFORE, CO IS UNABLE TO DRAW A CONCLUSION ABOUT THE CAUSE OF FAILURE. THE DEVICE WAS NOT RETURNED TO PHILIPS FOR INVESTIGATION. THE REPORTED DISPLAY MESSAGE, "ERROR 2", IS INDICATIVE OF THE DEFIBRILLATOR CHARGING TOO SLOW, CAUSING CHARGING TO ABORT. THE HOSPITAL'S RISK MGR AND THE EMERGENCY DEPT MGR BOTH REPORTED THAT THIS FAILURE DID NOT HAVE A SIGNIFICANT IMPACT TO THE OUTCOME OF THE PT. PHILIPS WAS FIRST MADE AWARE OF THE EVENT ON NOVEMBER 19, 2002. THE DEVICE IS CURRENTLY IN THE POSSESSION OF THE HOSPITAL. ACCORDING TO INFO PROVIDED BY THE COMPLAINANT, THE HOSPITAL'S BIOMEDICAL ENGINEERING DEPT REPAIRED THE DEVICE, BUT DID NOT RETURN IT TO SERVICE. THE HOSPITAL IS REPLACING ALL OF THEIR OLDER MODEL DEFIBRILLATORS WITH NEWER MODELS. THE SUBJECT DEVICE HAS BEEN IN USE SINCE 1990.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEWLETT - PACKARD DEFIBRILLATOR LDD PHILLIPS MEDICAL SYSTEMS 43100A *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening