BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRL PIC

    MDR report key: 321675 · Received March 16, 2001

    Report

    Report Number
    MW1021380
    Event Type
    Malfunction
    Date Received
    March 16, 2001
    Date of Event
    March 7, 2001
    Report Date
    March 15, 2001
    Manufacturer
    MEDICAL RESEARCH LABORATORY
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    911 DISPATCH FOR PT IN CARDIAC ARREST. CPR IN PROGRESS BY POLICE UPON ARRIVAL OF EMS. MRL PIC DEFIB PADS ATTACHED, UNIT SAID "LEAD FAULT." UNIT WOULD NOT SHOW HEART RHYTHM. UNABLE TO USE UNIT FOR DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11829 MRL PIC HEART MONITOR/DEFIBRILLATOR LDD MEDICAL RESEARCH LABORATORY PIC *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other