BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEPSAFE BED

    MDR report key: 18192104 · Received November 21, 2023

    Report

    Report Number
    MW5148374
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Report Date
    November 20, 2023
    Manufacturer
    SLEEPSAFE BEDS, LLC.
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I'M REPORTING SLEEP SAFE MEDICAL BEDS USED FOR AUTISTIC AND OTHER INDIVIDUALS WITH SEVERE COGNITIVE ISSUES. THERE HAVE BEEN MULTIPLE ONLINE POSTS SAYING THAT IN A FIRE BECAUSE OF LOCKING MECHANISM THAT THE CHILDREN WHO ARE LOCKED IN THIS BED CANNOT GET OUT WHICH IS THE POINT OF THE DEVICE, HOWEVER AGAIN THERE'S NO FIRE SAFETY EXIT POINT AND THESE CHILDREN AND EVEN ADULTS WHO USE THESE BEDS CANNOT GET OUT AND SUFFER FROM PHYSICAL AND OR MENTAL DISABILITY SO, EVEN IF THERE WAS A MECHANISM TO UNLOCK THE DOOR. THEY WOULD BE UNABLE TO PHYSICALLY UNDERSTAND, LET ALONE USE. A FAIL SAFE EXIT IN AN EMERGENCY THE BED IS BASICALLY LIKE A TIMEOUT ROOM ONE WAY IN AND OUT, AND THE ONLY ONE WHO CAN GET ACCESS TO THE INDIVIDUAL IN CASE OF EMERGENCY MEDICAL OR FIRE IS THE CARETAKER. HTTPS://SLEEPSAFEBED.COM/.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224154 SLEEPSAFE BED BED, MANUAL FNJ SLEEPSAFE BEDS, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown