BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER

    MDR report key: 301394 · Received October 23, 2000

    Report

    Report Number
    301394
    Event Type
    Malfunction
    Date Received
    October 23, 2000
    Date of Event
    October 9, 2000
    Report Date
    October 23, 2000
    Manufacturer
    AGILENT TECHNOLOGIES/CARDIAC PRODUCTS DIV
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF PADS ADAPTOR CABLE (M1750). WITH CABLE ATTACHED DEFIBRILLATOR INDICATES "NO PADDLES" (SAME INDICATION AS IF CABLE WERE NOT ATTACHED. ANALYSIS FINDS THAT CIRCUIT BOARD CONNECTOR WITHIN MAIN CONNECTOR ASSEMBLY PARTIALLY OUT OF RECEPTABLE JACK (FUNCTIONALLY DISCONNECTED). RESULTS OF THIS FAILURE MODE IS INABILITY TO OPERATE DEFIBRIALLTOR IN EXTERNAL PADS CONFIGURATION. THE NUMBER OF CABLE FAILURES WITH THIS FAILURE MODE NOW TOTAL FOUR. PREVIOUS REPORTS WERE DATED 12/07/1999 (10-8011-1999-0004), 12/14/1999 (10-8011-1999-0005) AND 01/18/2000 (10-8011-2000-0001).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER DEFIBRILLATOR LDD AGILENT TECHNOLOGIES/CARDIAC PRODUCTS DIV M1722 DEFIB *
    2 CODEMASTERS PADS ADAPTOR (CABLE) DSA AGILENT TECHNOLOGIES/CARDIAC PRODUCTS DIV M1750A/B *

    Patients

    Seq Age Sex Outcome Treatment
    1 *