BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERGOMETER STORAGE CART

    MDR report key: 3027596 · Received March 22, 2013

    Report

    Report Number
    1932056-2013-00001
    Event Type
    Other
    Date Received
    March 22, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    DPS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL POSITIONING INC, HAS BEEN SELLING THE STRESS ECHOBED WITH AN AVAILABLE STORAGE CART FOR OVER 15 YRS. THIS IS THE FIRST REPORT OF AN ERGOMETER CART TIPPING. MEDICAL POSITIONING, INC. HAS DETERMINED THAT THIS EVENT WAS CAUSED BY USER ERROR. HAD THE USER FOLLOWED THE INSTRUCTIONS IN THE OWNER'S MANUAL FOR LOCKING THE PRODUCT'S TRACK IN PLACE, THE EVENT WOULD NOT HAVE OCCURRED AT ALL.

    Description of Event or Problem · 1

    WHILE THE EVENT WAS REPORTED TO MPI ON (B)(6) 2013, MEDICAL POSITIONING, INC. DID NOT BECOME AWARE OF THE HAZARD INVOLVED IN THE REPORT UNTIL (B)(6) 2013 BECAUSE THE CUSTOMER DID NOT RESPOND TO THE COMPANY'S CONTACT ATTEMPTS FOR ALMOST ONE (1) MONTH AFTER THE EVENT OCCURRED. THERE WERE NO DEATH(S) OR SERIOUS INJURIES AS A RESULT OF THE EVENT. HOWEVER, MEDICAL POSITIONING, INC HAS DETERMINED THAT A RECURRENCE OF THE EVENT COULD LEAD TO A SERIOUS INJURY SUCH AS A BONE BREAK OR SERIOUS CONTUSION. THE ERGOMETER (EXERCISE BIKE) WAS BEING STORED ON ITS STORAGE CART. IT WAS FOUND THAT AN ADJUSTMENT LOCK WAS LEFT UNLOCKED BY THE USER, ALLOWING THE ERGOMETER TO SLIDE TO ONE SIDE CAUSING THE SYSTEM TO BECOME UNBALANCED. THE ERGOMETER WAS BUMPED BY THE USER IN ITS UNBALANCED STATE CAUSING THE CART TO TIP. WHILE NO INJURY OCCURRED IN THIS INSTANCE, A RECURRENCE COULD CAUSE A BROKEN BONE IF A BODY PART WAS IN THE WAY OF THE DEVICE AS IT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120935 ERGOMETER STORAGE CART ERGOMETER STORAGE CART - ACCESSORY DPS MEDICAL POSITIONING, INC. 11043 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other