BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 2501719 · Received February 27, 2012

    Report

    Report Number
    1218950-2012-00663
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Report Date
    February 1, 2012
    Manufacturer
    AGILENT TECHNOLOGIES, 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 CHARGE PROBLEM. THERE WAS NO REPORT OF PT INVOLVEMENT. THE SYMPTOM WAS CLARIFIED AS THE DEVICE FAILED TO CHARGE THE BATTERY DUE TO A FAILED POWER SUPPLY. THE CUSTOMER WAS INFORMED THAT THIS DEVICE HAS BEEN OUT OF SUPPORT SINCE (B)(6) 2006 AND PARTS ARE NO LONGER AVAILABLE. BASED ON THE CUSTOMER'S REPORT, WE WILL CONSIDER THIS A REPORTABLE MALFUNCTION OF THE UNIT. WE CANNOT CONCLUSIVELY DETERMINE THE CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CHARGE PROBLEM. THERE WAS NO REPORT OF PT INVOLVEMENT. THE SYMPTOM WAS CLARIFIED AS THE DEVICE FAILED TO CHARGE THE BATTERY DUE TO A FAILED POWER SUPPLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1