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

Model Number	246AQI
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Codes	External Prosthetic Device Pain (4560); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Aquari controller was found to be not pumping, no alarm.Hard reboot to get it to start pumping.Then noticed pump was running continuously.Leak isolated to foot section, replaced and tested ok.Patient was involved, however no injury was reported.

• Brand Name: AQUARI IMMERSION CONTROLLER
• Common Device Name: AIR FLOTATION PRESSURE MATTRESS
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 25131039
• Report Number: 2921578-2026-00013
• Device Sequence Number: 9326667
• Product Code: FNM
• UDI-Device Identifier: 00842430115936
• UDI-Public: (01)00842430115936
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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
• Device Model Number: 246AQI
• Device Catalogue Number: 246AQI
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown