MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. AQUARI IMMERSION CONTROLLER; AIR FLOTATION PRESSURE MATTRESS

Model Number	246AQI
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgical case the aquari pad deflated mid-procedure leaving the patient in direct contact with the metal table.
Additional Manufacturer Narrative
Information regarding injury or any impact to patient following the reported malfunction of the device was not obtained from the hospital.After the evaluation of the device, it was found that the reported issue of alarm not sounding was neither replicated nor reproduced.The root cause of the reported malfunction of the aquari controller was deemed to be the failure of pump motor.Execessive wear of the motor brush and subsquent high impedance state of the pump was deemed to be the cause of pump motor failure.
Event or Problem Description
It was reported that during surgical case the aquari pad deflated mid-procedure leaving the patient in direct contact with the metal table.

• Brand Name: AQUARI IMMERSION CONTROLLER
• Common Device Name: AIR FLOTATION PRESSURE MATTRESS
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 23306618
• Report Number: 2921578-2025-00019
• Device Sequence Number: 20284147
• Product Code: FNM
• UDI-Device Identifier: 00842430115936
• UDI-Public: (01)00842430115936(11)230518
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 246AQI
• Device Catalogue Number: 246AQI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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