MAUDE Adverse Event Report: KREG MEDICAL EZ WIDER BARIATRIC BED

Model Number	ASM100130
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: EZ WIDER BARIATRIC BED
• Common Device Name: EZ WIDER
• Manufacturer (Section D): KREG MEDICAL; 1940 janice ave; melrose park IL 60160
• Manufacturer (Section G): KREG MEDICAL; 1940 janice ave; melrose park IL 60160
• Manufacturer Contact: shweta khande ; 1940 janice ave; melrose park, IL 60160
• MDR Report Key: 22512222
• Report Number: 3005179379-2025-00013
• Device Sequence Number: 21144006
• Product Code: OSI
• UDI-Device Identifier: 00850520008075
• UDI-Public: (01)00850520008075(11)150625
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ASM100130
• Device Lot Number: 17
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Weight: 102 KG