AEGIS IMAGE MANAGEMENT
Received Oct 18, 1996 · Event occurred Sep 18, 1996
Report 2936884-1996-00001 · MDR key 44363
Device
Generic name
Picture Archiving And Communication System
Manufacturer
Acuson Corp.Model number
QV100Catalog number
NA
Lot number
NA
Patient
27 YR
Narrative
Description of Event or Problem
WHILE INVESTIGATING A QUESTIONABLE VALUE FOR FEMUR LENGTH ON AN OBSTETRICAL CALCULATIONS REPORT, THE REPORTER FOUND THAT A DIGIT 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 IN CONSULTATION WITH A PERINATOLOGIST, CO BELIEVES THE CHANCE OF SERIOUS INJURY IS REMOTE.
Remedial action
- Other