FDA.reportPublic FDA data

MAUDE MDR 470656

MDR report key
470656
Report number
1317307-2003-00003
Event key
0
Event type
3
Date of event
2003-06-08
Date received
2003-07-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHRISTINE EHMANN
Address
343 STATE STREET ROCHESTER NY 14650 US
Phone
585-585-5857
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KODAK X-OMAT MULTILOADER 7000X-RAY FILM PROCESSOREASTMAN KODAK COMPANYIXWML70001161967NANRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-07-0301. H

Event Narratives#

D

Patient 1

IN 2003, A HOSPITAL EMPLOYEE CALLED KODAK. WHEN KODAK RETURNED THE CALL TO THE HOSPITAL EMPLOYEE, THE EMPLOYEE'S FAMILY MEMBER INDICATED THAT THERE HAD BEEN A FIRE IN THE RADIOLOGY DEPARTMENT. THE KODAK REPRESENTATIVE WENT TO THE DEPARTMENT THE NEXT DAY AND WAS SHOWN, FROM A DISTANCE, THE KODAK X-OMAT MULTILOADER 7000 IN A BURNT STATE. THE INCIDENT SCENE HAD BEEN CLOSED OFF BY THE OFFICE OF PUBLIC SAFETY AND SECURITY. IT WAS INDICATED THAT TWO FIREMEN AND TWO HOSPITAL EMPLOYEES WERE TREATED AND RELEASED FOR SMOKE INHALATION. (THIS UNIT WAS INSTALLED AND SERVICED BY A KODAK DEALER, ELECTRO-MEDICAL/PROSOL.)