MAUDE Adverse Event Report: AGILITI HEALTH - CORONA RAYES, INC DBA SIZEWISE MANUFACTURING; SURFACE - ICU/MED-SURG (5-FOOT HOSE - PATIENT CARE PLUS)

Model Number	D2-3S3384-05-1B
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dabir hose is broken and did not alarm while in patient use.Patient's skin has been reported to have deteriorated while on surface.
Additional Manufacturer Narrative
Customer disposed of surface that was connected to tubing, therefore agiliti is unable to perform testing.

• Brand Name: RAYES, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: SURFACE - ICU/MED-SURG (5-FOOT HOSE - PATIENT CARE PLUS)
• 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: kari brower ; 252 mariah cir.; corona, CA 92879
• MDR Report Key: 22137785
• Report Number: 2030732-2025-00009
• Device Sequence Number: 17922835
• Product Code: FNM
• UDI-Device Identifier: 00845699046331
• UDI-Public: 00845699046331
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: D2-3S3384-05-1B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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: UDI (B)(4), CONTROLLER, SN (B)(6).
• Patient Sex: Unknown