BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL MOBILE STANDER

    MDR report key: 5994690 · Received October 3, 2016

    Report

    Report Number
    1319061-2016-00002
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    RIFTON EQUIPMENT
    Product Code
    KNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS ALMOST 20 YEARS OLD, LONG PAST THE DESIGN LIFE OF 5 YEARS. WE ARE WAITING FOR THE RETURN OF THE DEVICE TO CONDUCT FURTHER EVALUATION.

    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 OCCURED. 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 BACKWARDS AND HIT HIS HEAD, BUT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644806 SMALL MOBILE STANDER MOBILE STANDER KNL RIFTON EQUIPMENT K13

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR