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

Model Number	C3 HD3
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
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 processing with a hard reset of the scanner.
Event or Problem Description
A scanner malfunction due to a corrupted sd card delayed diagnostic imaging for a patient with low oxygen levels and elevated white cell count.Lung auscultation suggested pneumonia, while a chest x-ray raised concerns about pulmonary congestion.The patient's condition worsened, requiring increased oxygen support and eventual transfer to a larger facility.Limited diagnostics prevented timely intervention with diuretics, but the delay did not result in death or severe health deterioration.The malfunction was resolved with customer support assistance.

• 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: 20774543
• Report Number: 2023425-2024-00002
• Device Sequence Number: 20855136
• 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): 11/22/2024

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
• Device Model Number: C3 HD3
• Device Catalogue Number: 99-13-00018
• 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: 11/03/2024
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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