inforMED
MalfunctionLMB

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

QV100

Catalog 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