MAUDE Adverse Event Report: AGILITI HEALTH - HAYS RAYES, INC DBA SIZEWISE MANUFACTURING; BSWRP2 86

Model Number	12060308
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states bed alarm worked but did not signal the desk when patient fell out of bed.No patient injuries were sustained.
Additional Manufacturer Narrative
The bedframe was evaluated and it was found that the cable from the nurse call box, which connects to the rest secure system and provides connectivity of any alarm passing through the bedframe, was ripped out of the box.Replacement of nurse call box was completed to correct this issue.

• Brand Name: RAYES, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: BSWRP2 86
• 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: 22134330
• Report Number: 1931307-2025-00011
• Device Sequence Number: 7487120
• Product Code: FNL
• UDI-Device Identifier: 00845699003976
• UDI-Public: 00845699003976
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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: Lay User/Patient
• Device Model Number: 12060308
• 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: 05/05/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2014
• 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