FDA Adverse Event Malfunction Summary report: N

DIRECTVIEW CR SYSTEM

MDR report key: 531818 · Received May 26, 2004

Report

Report Number
531818
Event Type
Malfunction
Date Received
May 26, 2004
Date of Event
May 3, 2004
Report Date
May 11, 2004
Manufacturer
EASTMAN KODAK CO.
Product Code
MQB
Product Problem
Yes
Report Source
User Facility report
Reporter Location
DC, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

THE IDENTIFIED EQUIPMENT (HOSP HAS TWO) ARE CR (COMPUTED RADIOGRAPHY) PLATE READERS, WHICH "READ" IMAGING PLATES EXPOSED TO PT X-RAYS AND PRODUCE DIGITAL IMAGES. ON THIS DAY, BOTH UNITS BEGAN TO SHUT DOWN BY THEMSELVES. EFFORTS TO REBOOT THE SYSTEMS FAILED, THEY WOULD SIMPLY SHUT THEMSELVES DOWN IMMDIATELY AFTER RE-BOOTING. THE DEVICES CONTAIN A WINDOWS 2000 BASED PROCESSOR, WHICH IT WAS DETERMINED BY THE HOSP BECAME INFECTED WITH THE WIDESPEAD "SASSER" VIRUS BY WAY OF THE HOSP'S LAN, OVER WHICH THESE COMMUNICATE WITH KODAK LASER IMAGER, KODAK "REMOTE OPERATION PANELS" AND OTHER NETWORKED IMAGING EQUIPMENT. THE PROBLEM WAS RECTIFIED WHEN THE HOSP DOWNLOADED THE APPROPRIATE PATCH FROM THE MICROSOFT WEBSITE. KODAK WAS ABLE TO SUPPLY THE PATCH THE FOLLOWING DAY. DURING THE FEW HOURS THAT THE HOSP WAS DEALING WITH THIS VIRUS INFECTION REPORTER WAS UNABLE TO SCAN AND PRINT X-RAY IMAGES USING THEIR CR SYSTEMS. THIS DELAYED DIAGNOSIS AND TREATMENT DECISIONS. REPORTER IS CONCERNED THAT: 1) COMPUTERS WHICH FORM THE "HEART" OF MEDICAL EQUIPMENT AND SYSTEMS ARE OFTEN NOT THOUGHT OF AS COMPUTERS, BUT RATHER AS MEDICAL EQUIPMENT, AND THEREFORE VIRUS PROTECTIONS AND FIREWALLS ARE OFTEN NOT PROVIDED FOR THEM. THIS IS PARTICULARLY CRUCIAL WHEN THESE DEVICES COMMUNICATE VIA HOSPITAL LAN'S. AND 2) SOME VIRUS AND WORM INFECTIONS MAY EITHER COMPROMISE PT CONFIDENTIALITY (HIPAA CONCERNS) AND/OR ALTER THE OPERATION OF THE EQUIPMENT IN SUBTLE WAYS THAT ARE LESS NOTICEABLE THAN IN THIS CASE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DIRECTVIEW CR SYSTEM COMPUTED RADIOGRAPHY IMAGING PLATE READER MQB EASTMAN KODAK CO. CR-900 *
2 DIRECTVIEW CR SYSTEM COMPUTED RADIOGRAPHY IMAGING PLATE READER MQB EASTMAN KODAK CO. CR-900 *

Patients

Seq Age Sex Outcome Treatment
1 * Other