BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STAND 400 LB TO 500 LB

    MDR report key: 3245045 · Received July 18, 2013

    Report

    Report Number
    MW5030981
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 18, 2013
    Manufacturer
    EZ WAY
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NURSING HOME RESIDENT WAS STANDING FROM SITTING IN A WHEELCHAIR WITH THE ASSISTANCE OF THE EZ STAND MANUFACTURED BY EZ WAY, INC. (B)(4). THERE WERE TWO CERTIFIED NURSING ASSISTANCE HELPING WITH THE EZ STAND AND RESIDENT. AS THE STAND PICKED UP THE RESIDENT OUT OF THE WHEELCHAIR, THE ACTUATOR (HYDRAULIC ARM) BROKE AT THE BOLTED POINT OF CONNECTION TO THE LIFTING ARM ON THE EZ STAND. THE LIFTING ARM OF THE EZ STAND IMMEDIATELY WENT DOWN AND DROPPED THE RESIDENT WITH A THUD INTO HER WHEELCHAIR. THE ACTUATOR FELL TOWARD THE RESIDENT WITH THE SHARP BROKEN END FACING THE RESIDENT. WE OWN THREE EZ STANDS AND UPON CHECKING THE OTHER TWO WE FOUND EACH OF THEM WERE ABOUT TO BREAK AT THE CONNECTING POINT. THIS CONNECTION IS NOT ADEQUATE FOR THE TYPE OF MOTION IT PROVIDES IN THE MECHANICAL LIFT AND WILL WEAR OUT OVER TIME WITHOUT NOTICE TO THE OPERATOR. DATES OF USE: (B)(6) 2004 - (B)(6) 2013. REASON FOR USE: ASSIST IN STANDING FROM SITTING POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335230 EZ STAND 400 LB TO 500 LB EZ STAND FNG EZ WAY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention