BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ WAY STAND

    MDR report key: 3735837 · Received April 2, 2014

    Report

    Report Number
    2183887-2014-00001
    Event Type
    Death
    Date Received
    April 2, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 1, 2014
    Manufacturer
    EZ WAY, INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EZ WAY REPRESENTATIVE WENT TO THE FACILITY TO INVESTIGATE THE SITUATION. THE FACILITY CONTACT STATED THAT THE CNA WHO WAS TRANSFERRING THE RESIDENT DID NOT HAVE ANY TRAINING ON THE USE OF THE STAND AND NO LONGER WORKS AT THE FACILITY. THEY STATED THEY DID NOT REALLY KNOW WHAT HAPPENED. THE FACILITY REPLACED THE STAND ARMS WITH NEW ARMS AND SAFETY TABS. PER EZ WAYS OPERATING INSTRUCTIONS, ALL CAREGIVERS MUST RECEIVE TRAINING ON THE USE OF THE EQUIPMENT PRIOR TO USE WITH A PATIENT, AS WELL AS THE NEED TO CHECK TO SEE THAT ALL SAFETY EQUIPMENT SUCH AS THE SAFETY TABS IS IN PLACE PRIOR TO USE.

    Description of Event or Problem · 1

    A CNA WAS TRANSFERRING THE RESIDENT FROM A BED TO A WHEELCHAIR WITH AN EZ WAY STAND. DURING THE TRANSFER, THE LOOP OF THE HARNESS CAME OFF OF THE HOOK ON THE LEFT SIDE OF THE STAND ARM. THE SAFETY TAB ON THE HOOK WAS NOT ON THE HOOK OF THE LEFT SIDE WHERE THE LOOP CAME OFF THE HOOK. THE PATIENT FELL OUT OF THE HARNESS AND ONTO THE FLOOR. THE RESIDENT SUSTAINED TWO FRACTURED VERTEBRA. THE PATIENT WAS TAKEN TO THE HOSPITAL, AND RETURNED TO THE LONG TERM CARE FACILITY WHERE SHE EXPIRED 5 DAYS FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199723 EZ WAY STAND SIT TO STAND LIFTING DEVICE FNG EZ WAY, INC. 898 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death