BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R2 MULTIFUNCTION ELECTRODES

    MDR report key: 607966 · Received May 24, 2005

    Report

    Report Number
    3031042-2005-00031
    Event Type
    Malfunction
    Date Received
    May 24, 2005
    Date of Event
    May 3, 2005
    Report Date
    May 24, 2005
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN RESPONDING TO A CODE, THE PATIENT WAS SHOCKED ONE TIME. WHEN A 2ND SHOCK ATTEMPT WAS MADE, THE MRL PIC 50 DEFIBRILLATOR DISPLAYED "LEAD FAULT", AND THEY WERE UNABLE TO PACE. THE PATIENT EXPIRED. THE CUSTOMER STATED THEY DID NOT THINK THE PRODUCT PROBLEM IMPACTED THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R2 MULTIFUNCTION ELECTRODES MULTI-FUNCTION ELECTROCARDIOGRAPH ELECTRODES MLN BALLARD MEDICAL PRODUCTS NA 294870

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR