BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1501000 UPRIGHT BIKE

    MDR report key: 299548 · Received October 5, 2000

    Report

    Report Number
    MW1020109
    Event Type
    Malfunction
    Date Received
    October 5, 2000
    Date of Event
    September 25, 2000
    Report Date
    October 5, 2000
    Manufacturer
    SCIENTIFIC SOLUTIONS FOR FITNESS
    Product Code
    ION
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS RIDING STATIONARY EXERCISE BICYCLE AND SEAT BECAME "UNSECURED" FROM THE ADJUSTABLE PEG AND PROCEEDED TO DROP. SEAT FELL INTO THE HOME POSITION (ABOUT 8"). AFTER INSPECTION THE PEG THAT HOLDS THE SEAT IN PLACE WAS SHEARED APPROX 1/4" AT AN ANGLE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/28/00: THE EVENT REPORTED IS SOMETHING MFR WAS MADE AWARE OF 9/26/00. APPARENTLY THE END OF THE SEAT PIN BROKE OFF ALLOWING THE SEAT TO DROP TO ITS RESTING POSITION. IT HAD PREVIOUSLY BROKEN AND THE FACILITY CONTINUED TO USE THE DEVICE, ACCORDING TO ONE OF THE THERAPISTS WHO SPOKE TO CO'S SVC TECH. SCIFIT HAD IMMEDIATELY SENT OUT A NEW PART, BUT THE FACILITY CHOSE NOT TO INSTALL IT. THE SCIFIT UPRIGHT BIKE IS A SIMPLE STATIONARY UPRIGHT BIKE, WHICH IS SOLD TO FITNESS CENTERS AND PHYSICAL THERAPY. THE BIKE WAS MFG BY ASSOCIATED ENGINEERING OF LAKE FORREST, CA. IT IS NOT A CLASSIFIED FDA MEDICAL PRODUCT. SCIFIT IS NOT A FDA REGISTERED DEVICE ESTABLISHMENT, AS IT HAS NOT CLASSIFIED PRODUCTS IN ITS PRODUCT LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1501000 UPRIGHT BIKE STATIONARY BICYCLE ION SCIENTIFIC SOLUTIONS FOR FITNESS 1501000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other