BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 3761097 · Received December 31, 2013

    Report

    Report Number
    1218950-2013-06838
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Report Date
    December 10, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT THE BATTERY DID NOT HOLD A CHARGE ON THE CODEMASTER XL. FURTHER INFORMATION OBTAINED INDICATES THE CODEMASTER XL TURNS ON BUT EVEN IF IT IS CONNECTED TO THE NETWORK, IT DOES NOT HAVE ANY LIGHT THAT INDICATES PRESENCE ON NETWORK. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682638 CODEMASTER XL LDD, MKJ, DQA LDD PHILIPS MEDICAL SYSTEMS M1723A

    Patients

    Seq Age Sex Outcome Treatment
    1