MAUDE Adverse Event Report: DIGISONICS, INC. DOCTOR'S REVIEW SYSTEM (OBVIEW); PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Model Number	OB-VIEW 4.8.2 - 4.8.3
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When the ga (gestational age) by lmp (last menstrual cycle) is selected but the ga by sonographic is significantly discordant to that, it causes a discordance in the fw% (fetal weight percentile) because the fw itself is always based on sonographic measurements, but the fw% compares the fw to the normal range for the selected ga.

• Brand Name: DOCTOR'S REVIEW SYSTEM (OBVIEW)
• Common Device Name: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): DIGISONICS, INC.; 305 church at n hills st. 6th; north hills NC 27609
• Manufacturer (Section G): DIGISONICS, INC.; 305 church at n hills st. 6th; north hills NC 27609
• Manufacturer Contact: ashley brown ; 305 church at n hills st. 6th floor; north hills, NC 27609 ; 8282924758
• MDR Report Key: 17201748
• Report Number: 1626313-2023-00001
• Device Sequence Number: 12147605
• Product Code: LLZ
• UDI-Device Identifier: 00857050006014
• UDI-Public: 00857050006014
• Combination Product (Y/N): N
• PMA/510(K) Number: K970402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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: OB-VIEW 4.8.2 - 4.8.3
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown