MAUDE Adverse Event Report: AGILITI HEALTH - HAYS RAYE'S, INC DBA SIZEWISE MANUFACTURING; BARI REHAB PLATFORM 3 - 39"/48" X 80"

Model Number	45060100
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Testing has not yet been completed.An updated mdr will be sent upon testing completion.
Event or Problem Description
Hospital reported staff member had severe shoulder injury from attempting to move the bed and received treatment at er.Hospital reported bed in working condition and proceeded to place into patient use.
Additional Manufacturer Narrative
Out of an overabundance of caution the type of report was originally submitted as a '5-day' as we did not have all information available at the time of the initial report.It has been updated to '30-day'.Testing of the bed found that unit passed all testing with no problems found.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: BARI REHAB PLATFORM 3 - 39"/48" X 80"
• 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: kari brower ; 500 commerce pkwy; hays, KS 67601
• MDR Report Key: 22154438
• Report Number: 1931307-2025-00016
• Device Sequence Number: 20783279
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: 45060100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 06/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2020
• 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: Other
• Patient Sex: Unknown