BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ WIDER BARIATRIC BED

    MDR report key: 21651418 · Received March 20, 2025

    Report

    Report Number
    21651418
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    March 9, 2025
    Report Date
    March 10, 2025
    Manufacturer
    KREG MEDICAL INC.
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BARIATRIC PATIENT FELL THROUGH GAP IN UPPER AND LOWER BEDSIDE RAILS. PATIENT POSITION AT TIME OF FALL WAS WITH HEAD OF BED ELEVATED. PER REPORT, PATIENT WAS TRYING TO EITHER GRAB FOR AN ITEM ON THE BEDSIDE TABLE OR SIT AT EDGE OF BED. IN DOING SO, PATIENT SLIPPED HEADFIRST THROUGH THE GAP, LANDING ON FLOOR WITH LEGS CAUGHT IN BEDSIDE RAILING. AFTER COMPLETE ASSESSMENT PATIENT WAS FOUND TO BE UNHARMED. PATIENT HAS HISTORY OF FALLS (IS CURRENTLY ADMITTED RELATED TO FALL) AND CONFUSION. EZ WIDER HAD BEEN ORDERED DUE TO PATIENT¿S GIRTH HOWEVER AFTER FALL PATIENT WAS PLACED ON STANDARD HOSPITAL FRAME AND FOUND TO BE ABLE TO POSITION FREELY. BASED ON THIS FINDING, PATIENT¿S SIZE DID NOT REQUIRE A BARIATRIC FRAME. MANUFACTURER RESPONSE FOR BARIATRIC BED, EZ WIDE (PER SITE REPORTER). BED REMOVED FROM SERVICE AND PICKED BY COMPANY REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211980 EZ WIDER BARIATRIC BED BARIATRIC BED OSI KREG MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female