BEUDAMED
    FDA Adverse Event Summary report: N

    COMPLETE BRAIN IMC PROBE KIT

    MDR report key: 1061443 · Received June 13, 2008

    Report

    Report Number
    9617494-2008-00005
    Date Received
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    KIEL-MIELKENDORF
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE INCIDENT IS REPORTED BY THE PRODUCT MANAGER ON BEHALF OF THE FACILITY. THE DEVICE WAS REPORTEDLY GIVING A LOW TEMPERATURE READING. THE FACILITY WAS THEN ADVISED BY THE PRODUCT MANAGER TO USE THE MANUAL ENTRY AVAILABLE ON THE DEVICE. IT WAS AT THIS TIME THE DISCOVERY WAS MADE THAT THE DEVICE HAD BEEN INCORRECTLY PLACED. A PROTECTIVE SHEATH THAT COVERS AND PROTECTS THE SENSOR OF THE PROBE HAD NOT BEEN REMOVED PRIOR TO PLACEMENT. THE CORRECT INSERTION AND PLACEMENT OF THE PROBE IS LOCATED IN THE INSTRUCTIONS FOR USE, ALONG WITH DIAGRAMS AND SCHEMATICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE BRAIN IMC PROBE KIT NONE GWM KIEL-MIELKENDORF 050607A

    Patients

    Seq Age Sex Outcome Treatment
    1