AEGIS IMAGE MANAGEMENT
Received Nov 13, 1996 · Event occurred Oct 14, 1996
Report 2936884-1996-00004 · MDR key 50589
Device
Generic name
Picture Archinving And Communication System
Manufacturer
Acuson Corp.Model number
QV100Catalog number
NA
Lot number
NA
Patient
UNKNOWN
Narrative
Description of Event or Problem
WHILE INVESTIGATING 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 CO'S IMAGE AND DATA ACQUISITION SYSTEM. ENGINEERING TESTING HAS CONFIRMED THAT THE PROLEM OCCURS 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