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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  malfunction  

Event 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)
• Type of Device: 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
• MDR Text Key: 318139839
• Report Number: 1626313-2023-00001
• Device Sequence Number: 1
• Product Code: LLZ
• UDI-Device Identifier: 00857050006014
• UDI-Public: 00857050006014
• Combination Product (y/n): N
• PMA/PMN Number: K970402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• 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
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1