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

Model Number	246AQI
Medical Device Problem Codes	Use of Device Problem (1670); Gas/Air Leak (2946); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the end of the case, the pads were observed to be flat and the patient was operated on this flattened pad for an undetermined amount of time.
Event or Problem Description
It was reported that at the end of the case, the pads were observed to be flat and the patient was operated on this flattened pad for an undetermined amount of time.
Additional Manufacturer Narrative
Evaluation of pad sets observed a leak and o-ring of the hose was found to be missing.Hence causing desired pressure to not be maintained.The manufacturing date of the pad set was discovered to be 08/04/2022 which indicated that it may have been on service for ~3 years along with the tubing set.During this time the o-ring on the hose/tubing set is suspected to have cracked and/or go missing.The root cause of this incident is thus deemed to be use error as the user failed to inspect/check the components and accessories for damage/excessive wear or non-functioning parts as recommended in the owner's manual before use thus causing/contributing to the reported malfunction.

• 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: 23306382
• Report Number: 2921578-2025-00016
• Device Sequence Number: 20284145
• Product Code: FNM
• UDI-Device Identifier: 00842430115936
• UDI-Public: (01)00842430115936(11)220917
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2022
• 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
• Patient Sex: Unknown