BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL MOBILE STANDER

    MDR report key: 9794875 · Received March 5, 2020

    Report

    Report Number
    1319558-2020-00003
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    February 4, 2020
    Report Date
    March 5, 2020
    Manufacturer
    RIFTON EQUIPMENT
    Product Code
    KNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CENTER PANEL HAD CRACKED, CAUSING THE BODY SUPPORT TO SEPARATE FROM THE FRAME. IT IS LIKELY THAT THE CRACKS WOULD HAVE BEEN VISIBLE BEFORE THE FAILURE OCCURRED. THE PRODUCT MANUAL SAYS: "INSPECT THIS PRODUCT AND ACCESSORIES REGULARLY FOR LOOSE OR MISSING SCREWS, METAL FATIGUE, CRACKS, BROKEN WELDS, MISSING ATTACHMENTS, GENERAL INSTABILITY OR OTHER SIGNS OF EXCESSIVE WEAR. IMMEDIATELY REMOVE THIS PRODUCT FROM USE WHEN ANY CONDITION DEVELOPS THAT MIGHT MAKE OPERATION UNSAFE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIENT WAS USING THE STANDER WHEN A STRUCTURAL COMPONENT OF THE STANDER FAILED, ALLOWING THE BODY SUPPORT TO SEPARATE FROM THE FRAME OF THE STANDER. THE CLIENT REPORTEDLY FELL AND HIT HER HEAD, BUT WAS NOT SERIOUSLY INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259205 SMALL MOBILE STANDER MOBILE STANDER KNL RIFTON EQUIPMENT K130

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR