MAUDE Adverse Event Report: Unknown Reduced Gap Full Length Bed Rails; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number	6629
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	05/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient sustained a fracture to her right tibia and fibula when her leg became entrapped within the bed rail structure during an assisted transfer while the rails were in a lowered position.The patient was transferred to the hospital for further evaluation and treatment.Surgical intervention was recommended, but the family refused.The patient received bracing for her leg.
Additional Manufacturer Narrative
The 6629 bed rails were installed on a drive medical bed, model 15013-l, which is not an invacare product.The bed and rails were delivered to the patient on (b)(6) 2025.An invacare sps1080 mattress was also being used on the bed; it was delivered to the patient on (b)(6) 2026.There was no noted malfunction at the time of the event.Entrapment is a known risk when using bed rails.The 6629 bed rail assembly, installation and operating instructions warn, "entrapment may occur.Proper patient assessment and monitoring, and proper maintenance and use of equipment is required to reduce the risk of entrapment.Variations in bed rail dimensions, and mattress thickness, size or density could increase the risk of entrapment.Bed rails with dimensions different from the original equipment supplied or specified by the bed manufacturer may not be interchangeable and may result in entrapment or other injury." vitas healtchare was informed that the invacare mattress and rails may not be compatible with the drive medical bed, and it was recommended that they contact drive medical to confirm.The serial number provided for the bed rails (b)(6) is incomplete and was unable to be verified.Therefore, it is unclear when the rails were manufactured or by whom.The 6629 rails have been manufactured by invacare at invamex, and they have also been manufactured by a supplier and then distributed by invacare.Since the manufacturer cannot be confirmed, this report was filed under the invacare corporation dba invacare america registration.Should additional information become available, a supplemental record will be filed.

• Brand Name: Reduced Gap Full Length Bed Rails
• Common Device Name: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): Unknown
• Manufacturer Contact: dona bhamra ; one invacare way; elyria, OH 44035 ; +1(800)333-6900
• MDR Report Key: 50219959
• Report Number: 1531186-2026-00008
• Device Sequence Number: 21478773
• Product Code: LLI
• UDI-Device Identifier: 00841447102519
• UDI-Public: 00841447102519
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 6629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 135 LB