BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITOR/DEFIBRILLATOR/PACING PAD

    MDR report key: 36935 · Received September 6, 1996

    Report

    Report Number
    MW1009882
    Event Type
    Malfunction
    Date Received
    September 6, 1996
    Date of Event
    August 13, 1996
    Report Date
    August 23, 1996
    Manufacturer
    HEWLETT-PACKARD CO.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED IN ER WITH CPR IN PROGRESS; PACER PADS PLACED ANTERIORLY AND POSTERIORLY. PT IN V-FIB; DEFIBRILLATED THROUGH PACER PADS X2 WITHOUT PROBLEMS; ON 3RD DEFIBRILLATION ATTEMPT AN ELECTRICAL ARC ON ANTERIOR PAD WAS NOTED. AFTER THIS THE PACER WOULD NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONITOR/DEFIBRILLATOR/PACING PAD MONITOR/DEFIBRILLATOR/PACING PAD LDD HEWLETT-PACKARD CO. M1722A 1749A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other