BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 2456013 · Received February 10, 2012

    Report

    Report Number
    1218950-2012-00475
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Report Date
    January 18, 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 THAT AFTER HAVING DONE PREVENTIVE MAINTENANCE ON THE DEVICE THE DEVICE WOULD NO LONGER CHARGE THE BATTERY. THERE WAS NO PATIENT INVOLVEMENT. LOCAL PHILIPS SERVICE LATER DETERMINED THAT THE BATTERY WAS NO LONGER FUNCTIONAL AND THE DEVICE DID NOT RECOGNIZE AC MAINS AS A RESULT OF A FAILED POWER SUPPLY. THE PHILIPS BENCH EVALUATED THE DEVICE, CONFIRMED THE MALFUNCTION AND RESOLVED THE MALFUNCTION BY REPLACING THE BATTERY AND POWER SUPPLY WHICH WERE BOTH FOUND TO BE MALFUNCTIONING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER HAVING DONE PREVENTIVE MAINTENANCE ON THE DEVICE, THE DEVICE WOULD NO LONGER CHARGE THE BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    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