MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-04 for SKYTRON 6500NB * manufactured by Skytron.
[303452]
During surgical procedure, a fire erupted causing a physician's pant leg to catch on fire. The cause is unclear at this time and the bed, and electrical cords are being analyzed. The pt was not injured, however the physician suffered 2nd degree burns to the leg. Again, the cause is not certain at this time if it was the bed or the receptacle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 485263 |
| MDR Report Key | 485263 |
| Date Received | 2003-09-04 |
| Date of Report | 2003-08-07 |
| Date of Event | 2003-07-14 |
| Date Facility Aware | 2003-07-14 |
| Report Date | 2003-08-07 |
| Date Added to Maude | 2003-09-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | OR TABLE/BED |
| Product Code | BWN |
| Date Received | 2003-09-04 |
| Model Number | 6500NB |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 474150 |
| Manufacturer | SKYTRON |
| Manufacturer Address | 5000 36TH STREET GRAND RAPIDS MI 49512 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-04 |