BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LICOX OXYGEN MICRO-PROBE

    MDR report key: 511133 · Received January 16, 2004

    Report

    Report Number
    9617494-2004-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Report Date
    January 15, 2004
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDER
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NURSE CLINICAL EDUCATOR REPORTED DURING A CUSTOMER COURTESY VISIT, THE NICU DIRECTOR AND CLINICAL EDUCATOR REPORTED THE PLACEMENT OF THE LICOX OXYGEN CATHETER WAS NOT GOING SMOOTHLY. APPARENTLY THE RESIDENT HAS HAD TROUBLE INSERTING THE OXYGEN CATHETER PROPERLY AND IS KINKING THE CATHETER DURING INSERTION AND THE CATHETER BREAKS. AT TIMES IT HAS TAKEN HIM THREE KITS TO GET ONE CATHETER PLACED. TRAINING HAD BEEN PROVIDED IN JULY 2003. A CADAVER LAB WAS CONDUCTED FOR ALL RESIDENTS TO DEMONSTRATE PROPER PLACEMENT TECHNIQUE AND INTERVENTIONS. EACH PHYSICIAN WAS WALKED THROUGH THE PLACEMENT OF THE DEVICE INTO THE CADAVER. THE PHYSICIANS SEEMED TO UNDERSTAND THE PROPER PLACEMENT TECHNIQUE. INTEGRA'S CLINICAL EDUCATOR HAS BEEN ASKED TO RETURN TO THIS ACCOUNT IN THE SPRING TO CONDUCT ADDITIONAL TRAINING FOR THE NEW NURSES AND TO DISCUSS ANY CONCERNS WHICH MAY ARISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LICOX OXYGEN MICRO-PROBE LICOX BRAIN TISSUE OXYGEN MONITORING SYS GWM GESELLSCHAFT FUR MEDIZINISCHE SONDER * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *