BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ LIFT

    MDR report key: 17370069 · Received July 21, 2023

    Report

    Report Number
    17370069
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    June 18, 2023
    Report Date
    July 17, 2023
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BARIATRIC EZ STAND WAS FOUND TO BE DIFFICULT TO MANEUVER WHILE ATTEMPTING TO PIVOT A PATIENT FROM THE CHAIR TO THE BED. DURING THE ATTEMPT TO TRANSFER PATIENT, HER LEGS WEAKENED CAUSING HER ARMS TO FALL INTO THE SLING OF THE EZ STAND. PHYSICAL THERAPIST WAS ASSISTING PATIENT WHILE SHE WAS USING THE EZ STAND. IT WAS REPORTED THAT PATIENT "BUCKLED", LEAVING HER SUSPENDED BY HER ARMPITS IN THE EZ STAND. PHYSICAL THERAPIST WAS PRESENT AND ASSISTING APPROPRIATELY. 5 DAYS LATER, PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND REQUIRED INTENSIVE CARE UNIT (ICU) ADMISSION FOR SEVERE BLEEDING INTO HER AXILLARY AREA. IT IS BELIEVED THAT THIS IS A DIRECT RESULT OF THE EZ STAND INCIDENT. PATIENT RECEIVED MULTIPLE BLOOD PRODUCT TRANSFUSIONS, INTERVENTIONAL RADIOLOGY (IR) INTERVENTION, AND ULTIMATELY SURGERY TO STOP THE VERY SEVERE BLEED.

    Description of Event or Problem · 0

    BARIATRIC EZ STAND WAS FOUND TO BE DIFFICULT TO MANEUVER WHILE ATTEMPTING TO PIVOT A PATIENT FROM THE CHAIR TO THE BED. DURING THE ATTEMPT TO TRANSFER PATIENT, HER LEGS WEAKENED CAUSING HER ARMS TO FALL INTO THE SLING OF THE EZ STAND. PHYSICAL THERAPIST WAS ASSISTING PATIENT WHILE SHE WAS USING THE EZ STAND. IT WAS REPORTED THAT PATIENT "BUCKLED", LEAVING HER SUSPENDED BY HER ARMPITS IN THE EZ STAND. PHYSICAL THERAPIST WAS PRESENT AND ASSISTING APPROPRIATELY. 5 DAYS LATER, PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND REQUIRED INTENSIVE CARE UNIT (ICU) ADMISSION FOR SEVERE BLEEDING INTO HER AXILLARY AREA. IT IS BELIEVED THAT THIS IS A DIRECT RESULT OF THE EZ STAND INCIDENT. PATIENT RECEIVED MULTIPLE BLOOD PRODUCT TRANSFUSIONS, INTERVENTIONAL RADIOLOGY (IR) INTERVENTION, AND ULTIMATELY SURGERY TO STOP THE VERY SEVERE BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147008 EZ LIFT LIFT, PATIENT, NON-AC-POWERED FSA EZ WAY, INC. 8002

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA Female Required Intervention| H| O