inforMED
MalfunctionLMB

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 Corporation

Model number

QV100

Catalog 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