MAUDE Adverse Event Report: CLARIUS MOBILE HEALTH CORP. CLARIUS ULTRASOUND SCANNER; DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES

Model Number	C3 HD3
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device hardware was not physically returned to clarius.However, the device software (clarius app) was evaluated by clarius customer support team.The issue was successfully resolved by uninstalling and then reinstalling the application.The report was re-submitted on october 17th 2024 due to the following report failure notice: "the report identifier year is not valid".
Event or Problem Description
During a diagnostic evaluation in an emergency room in canada, a physician encountered a connectivity issue with clarius ultrasound scanner c3 hd3 while attempting to assess a patient presenting with abdominal pain and suspected fluid accumulation.The malfunction did not result in death, serious injury, or any significant adverse device-related outcomes.However, the malfunction caused a delay in diagnostic that could have exacerbate the patient's condition and lead to a death, serious injury or significant device experience if it were to reoccur in an emergency environment.The event was reported to clarius on september 11th, 2024 and the clarius scanner c3 hd3 has been cleared by the fda under 510(k) #k213436.The malfunction identified under this report occurred due to a connection issue between clarius app and clarius scanner because of a clarius app pilot update ( clarius app 11.3.1 to clarius app 11.3.2).The issue was successfully resolved by uninstalling and then reinstalling the application.

• Brand Name: CLARIUS ULTRASOUND SCANNER
• Common Device Name: DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES
• Manufacturer (Section D): CLARIUS MOBILE HEALTH CORP.; 2980 virtual way #205; vancouver, british columbia V5M 4 X3; CA V5M 4X3
• Manufacturer (Section G): CLARIUS MOBILE HEALTH CORP.; 2980 virtual way #205; vancouver, british columbia V5M 4 X3; CA V5M 4X3
• Manufacturer Contact: clara coutiere ; 2980 virtual way #205; vancouver, british columbia V5M 4-X3 ; CA V5M 4X3
• MDR Report Key: 20471171
• Report Number: 2023204-2024-00001
• Device Sequence Number: 20674817
• Product Code: IYN
• UDI-Device Identifier: 07540205001189
• UDI-Public: 07540205001189
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2024

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: C3 HD3
• 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: 09/11/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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