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

Model Number OB VIEW 4.8 TO 4.9

Device Problems Incorrect Measurement (1383); Inadequate User Interface (2958)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

When configured to use hadlock's alternate growth equations, the fl (femur length) normal percentile may be calculated incorrectly when near the top of the normal percentile range.This does not occur when the alternate growth equations are not configured.The actual femur length measurement is not affected, therefore the fetal weight measurements are also not affected (only the fl percentile).When the issue described above occurs, there is a possibility that the fetus will be incorrectly labelled as iugr (intrauterine growth restriction).No patient harm has been reported at this moment.This is merely a precautionary report.

• Brand Name: DOCTOR'S REVIEW SYSTEM (OBVIEW)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): DIGISONICS, INC; 3701 kirby dr; suite 930; houston TX 77098
• Manufacturer (Section G): DIGISONICS, INC.; 3701 kirby dr; suite 930; houston TX 77098
• Manufacturer Contact: chris pearce ; 3701 kirby dr; suite 930; houston, TX 77098 ; 7135297979
• MDR Report Key: 13207036
• MDR Text Key: 286341261
• Report Number: 1626313-2022-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: OB VIEW 4.8 TO 4.9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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