BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 2170837 · Received June 22, 2011

    Report

    Report Number
    1218950-2011-01790
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    June 1, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    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 THE LIGHTS OF THE POWER SUPPLY AND BATTERY CHARGER DO NOT WORK. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE UNIT WAS EVALUATED BY A PHILIPS AND THE REPORTED SYMPTOM WAS VERIFIED. THE POWER SUPPLY WAS REPLACED TO RESOLVE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE LIGHTS OF THE POWER SUPPLY AND BATTERY CHARGER DO NOT WORK. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1