BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMULATOR

    MDR report key: 26201 · Received September 28, 1995

    Report

    Report Number
    MW1007117
    Event Type
    Malfunction
    Date Received
    September 28, 1995
    Date of Event
    September 18, 1995
    Report Date
    September 22, 1995
    Manufacturer
    OLDELFT CORP. OF AMERICA
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE THERAPIST (EMPLOYEE) WAS SIMULATING A TREATMENT FIELD FOR A PT & WORKING INSIDE THE C-ARM ON THE COLUMN SIDE OF THE TABLE. THE PHYSICIAN WAS WORKING ON THE OTHER SIDE OF THE TABLE. THE THERAPIST WAS MOVING OUT OF THE MIDDLE OF THE C-ARM & ANOTHER THERAPIST WAS LOWERING THE TABLE. THE FIRST THERAPIST'S HAIR GOT CAUGHT IN THE SCREW MECHANISM ON THE COLUMN & PULLED OUT A SECTION OF HAIR ABOUT 2X6CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMULATOR SIMULATOR JAA OLDELFT CORP. OF AMERICA 11T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other