BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 2980199 · Received February 2, 2013

    Report

    Report Number
    1218950-2013-00352
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    January 9, 2013
    Manufacturer
    AGILENTTECHNOLOGIES, INC.
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE CHARGE TIME IN BATTERY MODE WAS EXCESSIVE. NO PT INVOLVEMENT WAS REPORTED. THE CUSTOMER EVALUATED THE DEVICE AND IDENTIFIED THE BATTERY AS THE CAUSE OF THE REPORTED SYMPTOM. THE CUSTOMER WAS INFORMED THAT THIS DEVICE HAS BEEN OUT OF SUPPORT SINCE (B)(4) 2006 AND PARTS ARE NO LONGER AVAILABLE. THE DEVICE REMAINS AT THE CUSTOMER SITE. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION OF THE BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CHARGE TIME IN BATTERY MODE WAS EXCESSIVE. NO PT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45961 CODEMASTER XL LDD, MKJ, DQA LDD AGILENTTECHNOLOGIES, INC. M1723A

    Patients

    Seq Age Sex Outcome Treatment
    1