BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISO1000 EXERCISE BICYCLE

    MDR report key: 4143278 · Received September 26, 2014

    Report

    Report Number
    4143278
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    April 16, 2014
    Report Date
    September 26, 2014
    Manufacturer
    SCIFIT SYSTEMS, INC.
    Product Code
    ION
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    GEAR WOULD NOT ENGAGE. PEDALS MOVED WITH NO RESISTANCE. EVALUATED BY BIOMED: DRIVE BELT CAME OFF, REPLACED BELT AND ADJUSTED BIKE TENSION. FUNCTION TEST COMPLETED AND PASSED. BIKE BACK IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600639 ISO1000 EXERCISE BICYCLE EXERCISER, NON-MEASURING ION SCIFIT SYSTEMS, INC. ISO1000 R *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES