FDA Adverse Event Malfunction Summary report: N

PICOM GATEWAY

MDR report key: 641853 · Received September 1, 2005

Report

Report Number
641853
Event Type
Malfunction
Date Received
September 1, 2005
Date of Event
August 16, 2005
Report Date
September 1, 2005
Manufacturer
SCIMAGE, INC.
Product Code
LMD
Product Problem
Yes
Report Source
User Facility report
Reporter Location
OH, US

Narratives

Description of Event or Problem · 1

THE PATIENT WAS HERE FOR A HEART CATH. THE PATIENT HAD PREVIOUS BYPASS SURGERY AND HAD RECURRING PAIN. THE STAFF TRIED TO ENTER THE PATIENT INFORMATION IN THE PICOM COMPUTER SEVERAL TIMES, WHICH ACQUIRES THE IMAGES DURING THE PROCEDURE. THE IMAGES ARE ALSO STORED ON THE DCI, X-RAY LIKE MACHINE, USED DURING THE CATH. AFTER THE PROCEDURE WAS DONE THE FACT THAT THE IMAGES WERE NOT ACQUIRED ON THE PICOM WAS REALIZED. THE IMAGES WERE SAVED ON THE DIGITAL COMPUTER IMAGER (DCI). THE TECHNICIAN WAS DONE MID DAY AND THE EARLIER PATIENT'S IMAGES WERE OK. AS IT TUNED OUT THE STAFF COULD NOT ENTER THE PATIENT INFORMATION BECAUSE THE COMPUTER WAS BEING WORKED ON BY THE MICROSOFT ADMINISTRATOR, SCIMAGE TECH SUPPORT AND OUR IT STAFF BECAUSE OF THE COMPUTER VIRUS PROBLEM IN THE HOSPITAL AND THE STAFF WERE LOCKED OUT OF THE SYSTEM. THE VIRUS PROBLEM WENT ON FOR A COUPLE OF DAYS BUT ONLY ONE PATIENT'S TEST WAS AFFECTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PICOM GATEWAY COMPUTER/PROGRAM LMD SCIMAGE, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 69 YR