BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMULATOR

    MDR report key: 6609644 · Received June 2, 2017

    Report

    Report Number
    1119903-2017-00002
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 3, 2017
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    BXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OCCUPATIONAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE ONLY AFFECTS ONE ATTACHMENT, TOOL 802, AND ONLY THIS PART HAD TO BE RETURNED TO BTE AND EVALUATED. THE SIMULATOR SYSTEM PERFORMANCE IS NOT AFFECTED ONCE THIS TOOL IS REPLACED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RECEIVED A REPLACEMENT TOOL (ATTACHMENT) ON 5/4/2017 BUT FOR OVER THREE WEEKS DID NOT SEND BACK TO BTE THE TOOL INVOLVED IN THE INCIDENT. THE TOOL WAS RECEIVED AT BTE ON 5/26/2017 LEAVING BTE INSUFFICIENT TIME TO COMPLETE THE INVESTIGATION BEFORE 6/2/2017 - THIRTY DAYS FROM THE INCIDENT DATE. THE REPORTED ISSUE ONLY AFFECTS ONE ATTACHMENT, TOOL 802, AND ONLY THIS ATTACHMENT HAD TO BE RETURNED TO BTE. THE SIMULATOR SYSTEM PERFORMANCE IS NOT AFFECTED. INSUFFICIENT TIME TO COMPLETE EVALUATION.

    Description of Event or Problem · 1

    PATIENT WAS USING THE TOOL 802 ATTACHED TO THE SIMULATOR WORKHEAD WHEN THE END HANDLE BROKE FROM TOOL, CAUSING HER ARM TO SLIP IN WHICH SHE THEN CUT HER FOREARM. THE PATIENT WAS TAKEN TO THE DOCTOR'S OFFICE. THE WOUND WAS CLEANED AND STERI-STRIPS WERE APPLIED. THE PATIENT RECEIVED A TETANUS SHOT AND AN X-RAY WAS TAKEN TO ENSURE NO METAL FRAGMENTS WERE LEFT IN HER ARM. THE PATIENT THEN RETURNED TO CLINIC TO COMPLETE THE FUNCTIONAL CAPACITY EVALUATION (FCE) AS SHE STATED SHE FELT WELL ENOUGH AND WANTED TO COMPLETE THE TESTING.

    Description of Event or Problem · 1

    PATIENT WAS USING THE TOOL 802 ATTACHED TO THE SIMULATOR WORKHEAD WHEN THE END HANDLE BROKE FROM TOOL, CAUSING HER ARM TO SLIP IN WHICH SHE THEN CUT HER FOREARM. THE PATIENT WAS TAKEN TO THE DOCTOR'S OFFICE. THE WOUND WAS CLEANED AND STERI-STRIPS WERE APPLIED. THE PATIENT RECEIVED A TETANUS SHOT AND AN X-RAY WAS TAKEN TO ENSURE NO METAL FRAGMENTS WERE LEFT IN HER ARM. THE PATIENT THEN RETURNED TO CLINIC TO COMPLETE FUNCTIONAL CAPACITY EVALUATION (FCE) AS SHE STATED SHE FELT WELL ENOUGH AND WANTED TO COMPLETE THE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388218 SIMULATOR SIMULATOR (BTE WORK SIMULATOR) BXB BTE TECHNOLOGIES, INC. SIMULATOR II SIM II

    Patients

    Seq Age Sex Outcome Treatment
    1 Other