BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPLETE BRAIN IMC PROBE KIT

    MDR report key: 5350694 · Received September 10, 2004

    Report

    Report Number
    9617494-2004-00024
    Event Type
    Other
    Date Received
    September 10, 2004
    Report Date
    September 9, 2004
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH
    Product Code
    GWM
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED. THIS INCIDENT HAS BEEN DETERMINED TO BE REPORTABLE SINCE PT MONITORING AND POSSIBLE TREATMENT MAY HAVE BEEN DELAYED DUE TO LATE SHIPMENT.

    Description of Event or Problem · 1

    THE PRODUCT SHOULD HAVE BEEN SHIPPED TO UNIVERSITY OF MARYLAND MEDICAL BUT WAS ACTUALLY SHIPPED TO INCORRECTLY TO THE HOME OF THE INTEGRA NEUROSPECIALIST ASSIGNED TO THAT AREA. THE INTEGRA NEUROSPECIALIST TOOK THE DEVICE TO THE HOSPITAL THE FOLLOWING DAY. OXYGEN MONITORING FOR THIS PT WAS DELAYED BY 24 HOURS DUE TO THE INCORRECT SHIPMENT OF DEVICE. NO PT INJURY WAS REPORTED DUE TO THIS DELAY. THE PT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE BRAIN IMC PROBE KIT BRAIN TISSUE OXYGEN MONITORING SYSTEM GWM GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH

    Patients

    Seq Age Sex Outcome Treatment
    1