BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 2508755 · Received March 26, 2012

    Report

    Report Number
    1218950-2012-01026
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Report Date
    March 2, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE BATTERY WAS NOT CHARGING. THERE WAS NO REPORT OF PT INVOLVEMENT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. REPLACEMENT OF THE AC POWER SUPPLY RESOLVED THE FAILURE. PHILIPS CONFIRMED THIS FAILURE AS A MALFUNCTION OF THE AC POWER SUPPLY. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTING AND REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY WAS NOT CHARGING. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL LDD, MKJ, DQA LDD PHILIPS MEDICAL SYSTEMS-DUP M1723B

    Patients

    Seq Age Sex Outcome Treatment
    1