MAUDE Adverse Event Report: AGILITI HEALTH - CORONA RAYE'S, INC DBA SIZEWISE MANUFACTURING; 35X82 IMMERSE UNIVERSAL MATTRESS

Model Number	7770-PUL1035UNV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Agiliti was awaiting a response from the customer to determine the patient's injury status.On (b)(6) 2026, the customer confirmed that the patient had fallen; however, the cause of the fall is unknown, and no additional information has been provided.The mattress and blower passed all testing.Further information is contained within complaint (b)(4).
Event or Problem Description
The patient fell from bed and sustained an acute fracture of the right superior pubic ramus.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: 35X82 IMMERSE UNIVERSAL MATTRESS
• Manufacturer (Section D): AGILITI HEALTH - CORONA; 252 mariah cir.; corona CA 92879
• Manufacturer (Section G): AGILITI HEALTH - CORONA; 252 mariah cir.; corona CA 92879
• Manufacturer Contact: bethany schultz ; 252 mariah cir.; corona, CA 92879
• MDR Report Key: 25487351
• Report Number: 2030732-2026-00001
• Device Sequence Number: 18575764
• Product Code: FNM
• UDI-Device Identifier: 00845699004393
• UDI-Public: 00845699004393
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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
• Device Model Number: 7770-PUL1035UNV
• 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: 04/16/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 120V IMMERSE BLOWER REV 3.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female