MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-24 for T-4 HELMET * 400-600 HELMET; 400-650 BATT manufactured by Stryker Instruments.
[18910998]
Approximately one hour and ten minutes into the case, the stryker hood worn by the scrub technician began to fog up and the team in the room smelled smoke. The technician tried to adjust the air flow, and it would not adjust. The technician left the field and removed the hood. She noted the wires inside the hood on the right were glowing once she removed it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038478 |
| MDR Report Key | 1038478 |
| Date Received | 2008-04-24 |
| Date of Report | 2008-04-24 |
| Date of Event | 2008-04-22 |
| Report Date | 2008-04-24 |
| Date Reported to FDA | 2008-04-24 |
| Date Added to Maude | 2008-05-08 |
| 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 | T-4 HELMET |
| Generic Name | MASK, SURGICAL HOOD/FILTER |
| Product Code | FXY |
| Date Received | 2008-04-24 |
| Model Number | * |
| Catalog Number | 400-600 HELMET; 400-650 BATT |
| Lot Number | 04145 HELMET; 07193 BATTERY |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1006373 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-24 |