MAUDE Adverse Event Report: AGILITI HEALTH - HAYS RAYES, INC DBA SIZEWISE MANUFACTURING; BARI REHAB PLATFORM2 (80")

Model Number	12060307
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bedframe was evaluated and found that customer was overinflating mattress on bedframe, which in turn presses on the siderail and makes it difficult to move the siderail.No issues were identified with the siderail.
Event or Problem Description
Facility states the rh siderail button would not engage in order to let the siderail down.6/4/2025 received confirmation that patient was on bedframe at time of reported issue.

• Brand Name: RAYES, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: BARI REHAB PLATFORM2 (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: 22146310
• Report Number: 1931307-2025-00015
• Device Sequence Number: 7634593
• Product Code: FNL
• UDI-Device Identifier: 00845699003952
• UDI-Public: 00845699003952
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace,Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12060307
• 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: 04/29/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2014
• 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