MAUDE Adverse Event Report: SONIO SONIO DETECT; AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE

Medical Device Problem Codes	Computer Software Problem (1112); Display or Visual Feedback Problem (1184); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Sonio detect software ai algorithm is faulty and wrongly labels fetal structures and associates them with the wrong body parts.The system will frequently display as visualized even though it hasn't leaving providers to give false normalcy and opening them up to liabilities.

• Brand Name: SONIO DETECT
• Common Device Name: AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE
• Manufacturer (Section D): SONIO
• MDR Report Key: 22340256
• Report Number: MW5171987
• Device Sequence Number: 11566945
• Product Code: QIH
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown