MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-03 for HI SUMMIT * manufactured by Howard Medical.
[3108040]
Smoke (no flames) came from equipment. Patients were evacuated from the area and there was no harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2900758 |
| MDR Report Key | 2900758 |
| Date Received | 2013-01-03 |
| Date of Report | 2013-01-03 |
| Date of Event | 2012-12-12 |
| Report Date | 2013-01-03 |
| Date Reported to FDA | 2013-01-03 |
| Date Added to Maude | 2013-01-08 |
| 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 |
| 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 | HI SUMMIT |
| Generic Name | CART |
| Product Code | NXB |
| Date Received | 2013-01-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOWARD MEDICAL |
| Manufacturer Address | 1690 N ELSTON AVE CHICAGO IL 60642 US 60642 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-03 |