MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-05 for LSI SOLUTIONS 110035 manufactured by Lsi Solutions.
[98994782]
Light cord became dislodged from fornisee device, which resulted in a burned drape. This event meets the joint commission of an operating room fire, and could have resulted in permanent injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075034 |
| MDR Report Key | 7240755 |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-31 |
| Date Added to Maude | 2018-02-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LSI SOLUTIONS |
| Generic Name | FORNISEE |
| Product Code | HEW |
| Date Received | 2018-02-05 |
| Model Number | 110035 |
| Lot Number | 692269 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS |
| Manufacturer Address | VICTOR NY 14564 US 14564 |
| Brand Name | LSI SOLUTIONS |
| Generic Name | FORNISEE |
| Product Code | LKF |
| Date Received | 2018-02-05 |
| Model Number | 110035 |
| Lot Number | 692269 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS |
| Manufacturer Address | VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-05 |