FDA Adverse Event
Other
Summary report: N
KODAK X-OMAT MULTILOADER 7000
MDR report key: 470656
·
Received July 3, 2003
Report
- Report Number
- 1317307-2003-00003
- Event Type
- Other
- Date Received
- July 3, 2003
- Date of Event
- June 8, 2003
- Report Date
- July 1, 2003
- Manufacturer
- EASTMAN KODAK COMPANY
- Product Code
- IXW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 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.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KODAK X-OMAT MULTILOADER 7000 | X-RAY FILM PROCESSOR | IXW | EASTMAN KODAK COMPANY | ML7000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |