MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-07-03 for KODAK X-OMAT MULTILOADER 7000 ML7000 1161967 manufactured by Eastman Kodak Company.
[321842]
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. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317307-2003-00003 |
| MDR Report Key | 470656 |
| Report Source | 05 |
| Date Received | 2003-07-03 |
| Date of Report | 2003-07-01 |
| Date of Event | 2003-06-08 |
| Date Mfgr Received | 2003-06-08 |
| Device Manufacturer Date | 2001-04-01 |
| Date Added to Maude | 2003-07-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTINE EHMANN |
| Manufacturer Street | 343 STATE STREET |
| Manufacturer City | ROCHESTER NY 14650 |
| Manufacturer Country | US |
| Manufacturer Postal | 14650 |
| Manufacturer Phone | 5857244487 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK X-OMAT MULTILOADER 7000 |
| Generic Name | X-RAY FILM PROCESSOR |
| Product Code | IXW |
| Date Received | 2003-07-03 |
| Model Number | ML7000 |
| Catalog Number | 1161967 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 459496 |
| Manufacturer | EASTMAN KODAK COMPANY |
| Manufacturer Address | 1401 WEST RIDGE RD. ROCHESTER NY 14652 US |
| Baseline Brand Name | KODAK X-OMAT MULTILOADER 7000 |
| Baseline Generic Name | X-RAY FILM PROCESSOR |
| Baseline Model No | ML7000 |
| Baseline Catalog No | 1161967 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-07-03 |