BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KREG CATALYST NON-BARIATRIC BED

    MDR report key: 24070250 · Received January 14, 2026

    Report

    Report Number
    MW5182230
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    October 27, 2025
    Report Date
    January 8, 2026
    Manufacturer
    KREG MEDICAL, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT SLID OUT THROUGH THE SIDE OF THE BED WHILE THE NURSE WAS OUT OF THE ROOM, DUE TO THE LARGE GAP BETWEEN THE BED AND THE RAILS. THE RIGHT HEAD RAIL WAS PARTIALLY DOWN, THE NURSE CALL CABLE WAS UNPLUGGED, AND THE BED ALARM--THOUGH REPORTEDLY ON--DID NOT SOUND UNTIL THE PATIENT WAS PLACED BACK IN BED. A CT SCAN SHOWED A BRAIN BLEED, BUT THE PATIENT REMAINED STABLE AND DID NOT REQUIRE HIGHER LEVEL OF CARE. AFTER TALKING TO THE MANUFACTURER, THEY HAVE INFORMED US THERE HAVE BEEN DESIGN UPDATES THAT HAVEN'T BEEN COMPLETED WITH THE SIDE RAILS AND TOLD STAFF TO USE SEIZURE PADS IN THE GAPS AS A FAIL SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138035 KREG CATALYST NON-BARIATRIC BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL KREG MEDICAL, INC. ASM100113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention