BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODEX RTM 600 TREADMILL

    MDR report key: 1956248 · Received January 5, 2011

    Report

    Report Number
    2431314-2010-00001
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    BXB
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    USER HAS A (B)(4) TREADMILL THAT HAS A NEW DISPLAY AND MOTOR CONTROL. USER WAS NOT USING THE SAFETY LANYARD THAT ATTACHES TO THE PATIENT AND WHEN PULLED SHUTS OFF THE TREADMILL. THEY DID NOT PRESS THE EMERGENCY STOP BUTTON THAT ALSO SHUTS OFF THE TREADMILL. THE SITE TOLD BIODEX THAT THE TREADMILL INCREASED IN SPEED BY ITSELF. IF PATIENT PRESSED THE SPEED INCREASE BUTTON THE TREADMILL SPEEDS UP. WE TESTED ANOTHER SIMILAR TREADMILL AND IT DOES NOT SPEED UP BY ITSELF. THE NEW TREADMILLS WERE TESTED AT BIODEX BEFORE SENDING TO CUSTOMERS. BOTH THE SAFETIES WORK ON THE TREADMILL WE HAVE IN HOUSE. WE ARE WAITING THE RETURN OF THE TREADMILL FROM THE CUSTOMER TO FURTHER ANALYZE THE TREADMILL. THE PATIENT FELL WHEN THE THERAPIST ATTEMPTED TO REMOVE THE PATIENT FROM THE TREADMILL WITHOUT STOPPING IT. THEY DID NOT PRESS THE EMERGENCY STOP OR PULL THE SAFETY LANYARD TO STOP THE TREADMILL BEFORE TRYING TO TAKE THE PATIENT OFF THE MOVING TREADMILL.

    Description of Event or Problem · 1

    AN ELDERLY WOMAN PATIENT WAS PLACED ON THE TREADMILL FOR REHAB. THE PHYSICAL THERAPIST AIDE HAD ADJUSTED THE UNIT SPEED OF 2.5 MPH. AS THE AIDE TURNED AWAY AFTER CONFIRMING NORMAL FUNCTION, LESS THAN A MINUTE LATER, THE TREADMILL WAS OPERATING AT A SPEED OF 7.5 MPH RESULTING IN THE PATIENT FALLING CAUSING INJURIES TO BOTH THE WOMEN'S SHOULDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIODEX RTM 600 TREADMILL TREADMILL BXB BIODEX MEDICAL SYSTEMS, INC. 950-420

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention