MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-07 for OPERATING ROOM LIGHT 6668 manufactured by Berchtold.
[16218172]
Pt was under general anesthesia when surgical light failed causing smoke and the fire department was called. Light was halogen surgical light with camera, manufactured by berchtold. This event was previously reported by (b)(6), on (b)(6) 2013. This follow-up report is to provide notice that we intend at this time to release the defective lamp to berchtold for evaluation. If you have any questions or concerns about this course of action, please feel free to contact us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032198 |
| MDR Report Key | 3404616 |
| Date Received | 2013-10-07 |
| Date of Report | 2013-10-04 |
| Date of Event | 2013-05-31 |
| Date Added to Maude | 2013-10-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPERATING ROOM LIGHT |
| Generic Name | OPERATING ROOM LIGHT |
| Product Code | FQP |
| Date Received | 2013-10-07 |
| Model Number | 6668 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-07 |