BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ WIDER BARIATRIC BED

    MDR report key: 22512222 · Received July 15, 2025

    Report

    Report Number
    3005179379-2025-00013
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    May 19, 2025
    Report Date
    July 15, 2025
    Manufacturer
    KREG MEDICAL
    Product Code
    OSI
    UDI-DI
    00850520008075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POST-INCIDENT PRODUCT INSPECTION & PREVENTIVE MAINTENANCE: THE BED FRAME INVOLVED IN THE INCIDENT WAS INSPECTED BY THE DISTRIBUTOR IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDED PREVENTIVE MAINTENANCE PROCEDURES. THE INSPECTION CONFIRMED THAT THE BED WAS OPERATING WITHIN ITS INTENDED DESIGN SPECIFICATIONS. CONTRIBUTING FACTORS AND DEVICE USE ASSESSMENT: BASED ON THE INITIAL COMPLAINT REPORT AND INFORMATION GATHERED, THE DEVICE APPEARS TO HAVE BEEN OPERATED OUTSIDE OF ITS INTENDED USE PARAMETERS: THE SIDE RAILS WERE NOT IN THE FULLY RAISED AND LOCKED POSITION, AS REQUIRED BY THE INSTRUCTIONS FOR USE (IFU). FOR PATIENT SAFETY, ALL SIDE RAILS MUST BE SECURED WHENEVER THE PATIENT IS UNATTENDED OR WHEN THE BED IS IN MOTION. THE BED EXIT ALARM WAS NOT ACTIVATED DURING USE. THIS FEATURE IS CRITICAL FOR PATIENT MONITORING, AND ITS NON-USE MAY HAVE CONTRIBUTED TO AN INCREASED RISK OF AN UNASSISTED BED EXIT. THE BED FRAME IS DESIGNED FOR DIRECT INTEGRATION WITH HOSPITAL MONITORING SYSTEMS VIA THE BED EXIT 37-PIN CONNECTORS. PROPER CONNECTION AND ACTIVATION OF THESE SYSTEMS ENHANCE PATIENT SAFETY AND MONITORING. THE PATIENT WAS ALSO PRONE TO SEIZURES.

    Description of Event or Problem · 0

    ON (B)(6) 2025, PATIENT (B)(6) ATTEMPTED TO EGRESS THE EZ WIDER BED THROUGH THE HEAD / FOOT RAILS. HE DID NOT CALL FOR ASSISTANCE. THE PATIENT SLIPPED AND FELL HEADFIRST SUSTAINING ORAL INJURIES (NO OTHER HEAD TRAUMA REPORTED). THE PATIENT HAD SEIZURE PRECAUTIONS, ALSO NEEDING EEG DEVICES. FALL PADS WERE ALSO IN USE AT THE TIME. ONE FOOT RAIL WAS DOWN AT THE TIME. THE PATIENT WAS NOTED AS BEING 6' AND 101.8KG. (224LBS.). EDUCATOR BROOKE REACHED OUT TO KREG INQUIRING ABOUT NURSE CALL CABLES FOR OUR BEDS.THE BED DID NOT HAVE A NURSE CALL CABLE ATTACHED TO THE BED. THERE IS ALSO A QUESTION AS TO WHY THE BED WAS ORDERED FOR THE PATIENT, GIVEN THE PATIENT WAS 224 LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535661 EZ WIDER BARIATRIC BED EZ WIDER OSI KREG MEDICAL ASM100130 17 00850520008075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown