BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEWLETT PACKARD

    MDR report key: 516219 · Received March 3, 2004

    Report

    Report Number
    MW1031423
    Event Type
    Injury
    Date Received
    March 3, 2004
    Date of Event
    February 21, 2004
    Report Date
    February 23, 2004
    Manufacturer
    *
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN CARDIAC ARREST HOOKED TO MONITOR, NO READING OBTAINABLE. DEFIBRILLATOR WORKING. SCREEN FOR MONITOR WOULD NOT SHOW ANY READINGS. TELEMETRY IN ICU SHOWING V FIB.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 5/6/04: THE ORIGINAL INFO RECEIVED ABOUT THIS EVENT INDICATED THAT THE MONITOR DISPLAY DID NOT SHOW ANY READINGS. FURTHER INVESTIGATION REVEALED THAT THE REPORTED PROBLEM WAS ACTUALLY A LOSS OF THE ECG LEADS DISPLAY. THE HOPSITAL'S BIOMEDICAL ENGINEER EVALUATED THE DEFIBRILLATOR AND COULD NOT REPRODUCE THE REPORTED PROBLEM. HE DID NOTE THAT THE GAIN CONTROL HAD BEEN TURNED DOWN TO ITS LOWEST SETTING. WHEN HE TESTED THE DEVICE WITH AN ECG SIMULATOR AND READJUSTED THE ECG GAIN CONTROL, THE ECG WAVEFORM BECAME VISIBLE ON THE DISPLAY. THE DEVICE PASSED ALL PERFORMANCE TESTS PERFORMED BY THE BIOMEDICAL ENGINEER. THE DEVICE WAS NOT RETURNED TO PHILIPS MEDICAL SYSTEMS FOR EVALUATION. THE BIOMEDICAL ENGINEER'S FINDINGS INDICATE THAT THE ECG WAVEFORM WAS NOT VISIBLE ON THE DISPLAY BECAUSE A USER HAD TURNED DOWN THE ECG GAIN. BASED ON DISCUSSIONS WITH THE HOSPITAL'S DIRECTOR OF NURSING, THERE WAS NO DELAY IN DELIVERING DEFIBRILLATION THERAPY AND THE EVENT PLAYED NO ROLE IN THE OUTCOME OF THE PT. THE PT INVOLVED IN THIS INCIDENT WAS AN ELDERLY, FRAIL PT. PT WAS SUCCESSFULLY RESUSCITATED BY THE DEVICE AND WAS BROUGHT TO I.C.U., WHERE THEY DIED SEVERAL DAYS LATER. THE DEFIBRILLATION FUNCTIONALITY OF THE DEVICE WAS FUNCTIONING PROPERLY DURING THIS EVENT. PHILIPS MEDICAL SYSTEMS RECEIVED FDA LETTER, DATE MARCH 25, 2004, ON APRIL 7, 2004. THIS WAS THE ONLY NOTIFICATION RECEIVED BY PHILIPS MEDICAL SYSTEMS REGARDING THIS EVENT. THE DEFIBRILLATOR, TO THE BEST OF MFR'S KNOWLEDGE, IS BEING USED AS A BACK-UP DEFIBRILLATOR IN THE HOSPITAL'S I.C.U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEWLETT PACKARD DEFIBRILLATOR - MONITOR LDD * 78670A *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R