BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RTM 600 TREADMILL

    MDR report key: 4261723 · Received November 15, 2014

    Report

    Report Number
    2431314-2014-00001
    Event Type
    Injury
    Date Received
    November 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    October 28, 2014
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    IOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIODEX WAS NOTIFIED (B)(4) 2014 ABOUT THE PROBLEM. WE WERE TOLD THE PATIENT WAS INSTRUCTED HOW TO USE THE TREADMILL AND THEN WAS NOT SUPERVISED. WITH PRESSING THE SPEED BUTTON CONTINUOUSLY THE MILL SPED UP TOO FAST AND PATIENT FELL OFF. THEY DID NOT USE THE EMERGENCY STOP BUTTON, STOP BUTTON ON THE DISPLAY OR THE SAFETY LANYARD. ALL OF WHICH WILL DISABLE UNIT. BIODEX IS WAITING TO ANALYZE THE UNIT. RESPONSE TO 4H-3: BIODEX MEDICAL SYSTEMS IS WAITING TO HEAR FROM THE CUSTOMER SO WE CAN GO IN AND EVALUATE THE SYSTEM, DETERMINE THE CAUSE AND MAKE REPAIRS, IF NECESSARY.

    Description of Event or Problem · 1

    PATIENT FELL OFF TREADMILL AND DISLOCATED HER SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740410 RTM 600 TREADMILL TREADMILL IOL BIODEX MEDICAL SYSTEMS, INC. 950-280

    Patients

    Seq Age Sex Outcome Treatment
    1