BEUDAMED
    FDA Adverse Event Summary report: N

    PRO1000

    MDR report key: 3072527 · Received April 15, 2013

    Report

    Report Number
    3072527
    Date Received
    April 15, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SCIFIT SYSTEMS, INC.
    Product Code
    BXB
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    CLINICAL ENGINEER'S PANTLEG WAS CAUGHT ON THE ADJUSTABLE EXTENSION SHAFTS, WHICH PULLED HIS LEG TOWARD THE PINCH POINT ON THE ERGOMETER. NO INJURY, THOUGH IT POTENTIALLY COULD CAUSE A SPRAIN. A GOOD SOLUTION WOULD TO PLACE A SOFT COVER OVER THE SHAFTS OR REDESIGN THE ASSEMBLY SOMEHOW.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162024 PRO1000 EXERCISER, POWERED BXB SCIFIT SYSTEMS, INC. PRO 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *