AEGIS IMAGE MANAGEMENT
Received Oct 24, 1996 · Event occurred Sep 19, 1996
Report 2936884-1996-00002 · MDR key 45351
Device
Generic name
Picture Archiving And Communication System
Manufacturer
Acuson CorporationModel number
QV100Catalog number
NA
Lot number
NA
Patient
NO INFO
Narrative
Description of Event or Problem
WHILE INVESTIGATING A QUESTIONABLE VALUE FOR HEAD CIRCUMFERENCE ON AN OBSTETRICAL CALCULATIONS REPORT, THE INITIAL REPORTER FOUND THAT TWO DIGITS HAD BEEN OMITTED WHEN COMPARED TO THE DATA SAVED IN THE ULTRASOUND SYSTEM. THE DIGIT WAS OMITTED DURING TRANSMISSION OF THE ULTRASOUND DATA TO AN IMAGE AND DATA ACQUISITION SYSTEM. ENGINEERING TESTING HAS CONFIRMED THAT THE PROBLEM OCCURS INTERMITTENTLY AND INFREQUENTLY. THIS MEASUREMENT CAN BE USED IN DETERMINING FETAL WEIGHT AND GESTATIONAL AGE. BASED ON CONSULTATION WITH A PERINATOLOGIST, CO BELIEVES THE CHANCE OF SERIOUS INJURY IS REMOTE.
Remedial action
- Other