BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 2140607 · Received June 16, 2011

    Report

    Report Number
    1218950-2011-01722
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AGILENTTECHNOLOGIES, INC.
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILURE TO CHARGE AFTER THE DEVICE DELIVERS 3 SHOCKS IN A ROW. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO CHARGE AFTER THE DEVICE DELIVERS 3 SHOCKS IN A ROW. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL LDD,MKJ,DQA LDD AGILENTTECHNOLOGIES, INC. M1723B

    Patients

    Seq Age Sex Outcome Treatment
    1