BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTERG ANTI-GRAVITY TREADMILL

    MDR report key: 4459680 · Received January 26, 2015

    Report

    Report Number
    3007033433-2015-00001
    Event Type
    Injury
    Date Received
    January 26, 2015
    Date of Event
    January 16, 2015
    Report Date
    January 22, 2015
    Manufacturer
    ALTERG, INC
    Product Code
    IOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTERG INC. WILL ADDRESS THE ISSUE BY NOTIFYING ALL CUSTOMERS ON THE IMPORTANCE OF ENSURING PATIENT STABILITY BEFORE ENTRY/EXIT OF ALTERG EQUIPMENT TO PROTECT PATIENTS FROM FOLLOWING TRANSITIONS.

    Description of Event or Problem · 1

    A PATIENT WAS INJURED EXITING THE F320 PRODUCT AFTER A WORKOUT SESSION. ACCORDING TO THE DIRECTOR OF REHAB AT THE FACILITY, THE PATIENT HAS JUST ENDED HIS SESSION AND WAS HAVING HIS VITALS TAKEN. WHILE EXITING THE TREADMILL, THE COCKPIT WAS UNLOCKED; THE PATIENT WAS NOT VERTICALLY STABLE AND PUT WEIGHT ON HIS HEELS. THIS CAUSED THE TREADMILL BELT TO MOVE FORWARD, CAUSING HIS FEET TO SLIDE OUT FROM UNDER HIM. THE PATIENT COULD NOT STOP THE MOMENTUM, NOR COULD THE PT AIDING THE PATIENT. THE PATIENT SAT ON THE REAR OF THE COCKPIT, WHICH ADDED FURTHER WEIGHT AND MOMENTUM TO THE FALL, HIS LEGS FELL OUT IN FRONT OF HIM, AND WERE PINNED UNDER THE FRONT OF THE COCKPIT. NOTE THE PATIENT HAD BEEN IN THE EQUIPMENT ONCE BEFORE. HE WAS CONSIDERED A MINIMUM-ASSIST PATIENT, AND WAS WEARING A GAIT BELT. THE PT WAS TO THE SIDE OF THE EQUIPMENT, AND WAS UNABLE TO ASSIST THE PATIENT TO STAND-UP VERTICALLY ONCE THE PROCESS BEGAN, NOR TO STOP THE PROGRESS OF THE BELT SLIPPAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58832 ALTERG ANTI-GRAVITY TREADMILL IOL, TREADMILL POWERED IOL ALTERG, INC F320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention