MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-04-18 for KODAK X-OMAT 180LP PROCESSOR 1623941 manufactured by Eastman Kodak Company.
[58808]
Alleged overheating of recirculation pump motor resulted in fire. Hosp personnel unable to extinguish flames. The facility called fire dept to put fire out. Radiology dept was evacuated due to smoke. One person filed report of smoke inhalation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1315356-1997-00002 |
| MDR Report Key | 86164 |
| Report Source | 04 |
| Date Received | 1997-04-18 |
| Date of Report | 1997-02-25 |
| Date of Event | 1997-02-22 |
| Date Mfgr Received | 1997-02-24 |
| Device Manufacturer Date | 1994-02-01 |
| Date Added to Maude | 1997-04-25 |
| 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 | BIOMEDICAL ENGINEER |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK X-OMAT 180LP PROCESSOR |
| Generic Name | RADOPGRAPHIC FILM PROCESSOR |
| Product Code | IXW |
| Date Received | 1997-04-18 |
| Model Number | NA |
| Catalog Number | 1623941 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 85358 |
| Manufacturer | EASTMAN KODAK COMPANY |
| Manufacturer Address | 901 ELMGROVE RD ROCHESTER NY 14653 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-18 |