BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-GRAVITY TREADMILL

    MDR report key: 6621552 · Received June 8, 2017

    Report

    Report Number
    3007033433-2017-00001
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    April 4, 2017
    Report Date
    January 6, 2017
    Manufacturer
    ALTERG, INC.
    Product Code
    BXB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTERG HAS DETERMINED THAT THE FAILURE WAS DUE TO A FAULTY IC. THE IC WAS IDENTIFIED AS SUSPECT PREVIOUSLY AND HAS BEEN SUBSTITUTED WITH ALTERNATIVE IN MAY 2016. A HAZARD ANALYSIS OF THE REPORTED PROBLEM WAS PERFORMED THT INDICATED THE POTENTIAL FOR FAILURE CAN EXT TO OCCUR (B)(4) USES OF THE PRODUCT. THERE HAVE BEEN NO REPORTED INJURIES DUE TO THIS EVENT. ALTERG WILL ADDRESS THE FAULTY COMPONENT IN THE FIELD VIA REPAIR NOTICE TO ALL DISTRIBUTORS AND OFFER FREE REPLACEMENT PARTS.

    Description of Event or Problem · 1

    AS REPORTED BY DISTRIBUTOR: PROBLEM DESCRIPTION: - NEW PATIENT WAS IN THE M320, READY TO START CALIBRATION - WHEN PRESSING START, THE TREADMILL DID NOT CALIBRATE BUT THE TREADMILL WENT IMMEDIATELY TO MAX SPEED. THE BELT DID NOT STOP WHEN PULLING THE SAFETY LANYARD: EMERGENCY STOP DID NOT WORK! - PATIENTS SHOE SOLES AND SHOE TOES WERE SERIOUSLY DAMAGED BY THE ABRASIVE BELT. - THE M320 COULD ONLY BE STOPPED BY INTERRUPTING THE POWER: THIS FAST ACTION BY THE THERAPIST PREVENTED THE PATIENT OF BEING HURT. WE DID SERVICE THE M300-0446 IMMEDIATELY: REPLACING THE MOTOR CONTROLLER BOARD 102647 DID SOLVE BOTH PROBLEMS: MAX. SPEED AND EMERGENCY STOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402368 ANTI-GRAVITY TREADMILL MODEL M320 BXB ALTERG, INC. M320

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention