BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIFTON DYNAMIC STANDER

    MDR report key: 2538218 · Received April 10, 2012

    Report

    Report Number
    1319558-2012-00001
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    March 9, 2012
    Report Date
    April 10, 2012
    Manufacturer
    RIFTON EQUIPMENT
    Product Code
    KNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS NEARLY 13 YEARS OLD AND HAD CHANGED HANDS AT LEAST ONCE. IT APPEARS TO HAVE BEEN POORLY MAINTAINED AND IN BAD REPAIR PRIOR TO THE INCIDENT. PRELIMINARY ANALYSIS SUGGESTS THAT THERE WOULD LIKELY HAVE BEEN VISIBLE CRACKING OF THE PART WELL BEFORE THE ALLEGED FAILURE THAT RESULTED IN THIS INCIDENT. SUCH CRACKING WOULD BE OBVIOUS TO A USER COMPLYING WITH THE INSTRUCTION IN THE DEVICE MANUAL TO PERIODICALLY INSPECT THE DEVICE FOR CRACKS. IT IS POSSIBLE THAT THE DEVICE WAS USED TO A MANNER FOR WHICH IT WAS NOT INTENDED. THE PRODUCT MANUAL INSTRUCTIONS SAY: "PERIODICALLY INSPECT FOR CRACKS, BREAKS, LOOSE OR MISSING PARTS, AND/OR MALFUNCTIONS. REMOVE THE PRODUCT FROM SERVICE WHEN ANY CONDITION DEVELOPS THAT MIGHT MAKE OPERATION UNSAFE."

    Description of Event or Problem · 1

    WE UNDERSTAND THAT A STRUCTURAL COMPONENT OF THE STANDER FAILED, ALLOWING THE BODY SUPPORT MECHANISM TO SEPARATE FROM THE FRAME OF THE STANDER. THIS APPARENTLY CAUSED THE USER OF THE DEVICE TO FALL AND SUSTAIN A SLIGHT FRACTURE OF HER LEFT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIFTON DYNAMIC STANDER KNL - BOARD, SCOOTER, PRONE KNL RIFTON EQUIPMENT K15 K1519990821AB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention