inforMED
MalfunctionLMB

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

QV100

Catalog 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