MAUDE Adverse Event Report: Agiliti Health - Hays RAYE'S, Inc dba Sizewise Manufacturing; BRP3 394880

Model Number	45060100
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The bed frame was stuck in an elevator and not working.Then the device went into reverse and kept backing into a medical center employee injuring their left shoulder and left upper back.
Additional Manufacturer Narrative
The bed frame was evaluated, and the reported issue could not be reproduced.The power drive operated as intended throughout testing.Further information is contained within (b)(4).

• Brand Name: RAYE'S, Inc dba Sizewise Manufacturing
• Common Device Name: BRP3 394880
• Manufacturer (Section D): Agiliti Health - Hays; 500 commerce pkwy; hays KS 67601
• Manufacturer (Section G): Agiliti Health - Hays; 500 commerce pkwy; hays KS 67601
• Manufacturer Contact: bethany schultz ; 500 commerce pkwy; hays, KS 67601 ; +1(507)261-5682
• MDR Report Key: 50613467
• Report Number: 1931307-2026-00004
• Device Sequence Number: 10742573
• Product Code: FNL
• UDI-Device Identifier: 00845699002238
• UDI-Public: 00845699002238
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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
• Device Model Number: 45060100
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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: Required Intervention
• Patient Sex: Unknown