BEUDAMED
    FDA Adverse Event Other Summary report: N

    LICOX CMP OXYGEN MONITOR

    MDR report key: 554132 · Received April 29, 2004

    Report

    Report Number
    9617494-2004-00015
    Event Type
    Other
    Date Received
    April 29, 2004
    Report Date
    April 29, 2004
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH
    Product Code
    GWM
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MONITOR WILL NOT BE RETURNED. THE MONITOR DID NOT MALFUNCTION. THE MONITOR DID NOT REACH THE HOSP ON TIME FOR PT MONITORING. THESE MONITORS WERE ORDERED FOR A PT WHO WAS TO INITIATE MONITORING IN APRIL 2004. THE FACILITY ORDERED THESE TO BE SHIPPED FEDERAL EXPRESS PRIORITY. THE DISTRIBUTION CENTER SHIPPED UPS GROUND, FOR WHICH THESE MONITORS WILL NOT ARRIVE AT THE USER SITE UNTIL 6 DAYS LATER. THE PT'S PLAN OF TREATMENT AND MONITORING HAD TO BE AMMENDED UNTIL THE MONITOR FINALLY DID REACH THE HOSP. NO PT INJURY RESULTED FROM THE DELAY IN SHIPMENT BUT THE PT'S TREATMENT WAS MODIFIED DUE TO SHIPMENT INCONVENIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LICOX CMP OXYGEN MONITOR LICOX BRAIN TISSUE OXYGEN MONITORING GWM GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH AC3.1 VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 *