MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-04-11 for KODAK X-OMAT 180 LP PROCESSOR 162 3941 manufactured by Eastman Kodak Company.
[16763225]
While under power processor in main radiology dept caught fire. There were no injuries and no radiographs destroyed. The fire dept was called and extinguished the fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1315356-1997-00001 |
| MDR Report Key | 84523 |
| Report Source | 04 |
| Date Received | 1997-04-11 |
| Date of Report | 1997-02-07 |
| Date of Event | 1997-02-07 |
| Date Mfgr Received | 1997-02-11 |
| Device Manufacturer Date | 1994-09-01 |
| Date Added to Maude | 1997-04-21 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK X-OMAT 180 LP PROCESSOR |
| Generic Name | RADIOGRAPHIC FILM PROCESSOR |
| Product Code | IXW |
| Date Received | 1997-04-11 |
| Model Number | 180 LP |
| Catalog Number | 162 3941 |
| Lot Number | N/A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 83781 |
| Manufacturer | EASTMAN KODAK COMPANY |
| Manufacturer Address | 343 STATE STREET ROCHESTER NY 14650 US |
| Baseline Brand Name | KODAK X-OMAT 180 LP PROCESSOR |
| Baseline Generic Name | RADIOGRAPHIC FILM PROCESSOR |
| Baseline Model No | 180 LP |
| Baseline Catalog No | 1623941 |
| Baseline ID | NONE |
| Baseline Device Family | X-OMAT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K921269 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-11 |