BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE LEAD SET AAMI

    MDR report key: 1051962 · Received May 22, 2008

    Report

    Report Number
    1218950-2008-00275
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    April 24, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEADS ARE BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE LEAD SET AAMI CARDIOGRAPH DRX PHILIPS MEDICAL SYSTEMS 989803129161

    Patients

    Seq Age Sex Outcome Treatment
    1