MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. AQUARI IMMERSION CONTROLLER REFURB; EXTERNAL CUFF/PAD INFLATION TUBING SET

Model Number	246AQIR
Medical Device Problem Codes	Device Alarm System (1012); Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
O rings on the ends of the hoses deteriorated and broke apart.Without the o rings, the aquari pads do not maintain air pressure and slowly deflate.This sometimes triggers the error on the aquari unit "pads too soft".Other times it does not send an alarm and instead the pads slowly deflate which creates a patient safety risk.
Additional Manufacturer Narrative
The original evaluation of the incident deemed as non-reportable was about the request for replaceable o-rings.Considering the additional note about an occasion when the alarm failed to display as expected, the event was retrospectively evaluated as reportable.
Additional Manufacturer Narrative
The original evaluation of the incident deemed as non-reportable was about the request for replaceable o-rings.Considering the additional note about an occasion when the alarm failed to display as expected, the event was retrospectively evaluated as reportable.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.Excessive wear of the motor brush and subsequent high impedance state of the pump was deemed to be the cause of pump motor failure.
Event or Problem Description
O rings on the ends of the hoses deteriorated and broke apart.Without the o rings, the aquari pads do not maintain air pressure and slowly deflate.This sometimes triggers the error on the aquari unit "pads too soft".Other times it does not send an alarm and instead the pads slowly deflate which creates a patient safety risk.

• Brand Name: AQUARI IMMERSION CONTROLLER REFURB
• Common Device Name: EXTERNAL CUFF/PAD INFLATION TUBING SET
• 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: 23537738
• Report Number: 2921578-2025-00021
• Device Sequence Number: 10186679
• Product Code: FNM
• UDI-Device Identifier: 00842430115936
• UDI-Public: (01)00842430115936(11)230929
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 246AQIR
• Device Catalogue Number: 246AQIR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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