MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-30 for SIEMENS MOLECULAR IMAGING DIVISION E-CAM * manufactured by *.
[612227]
Smoke, sparks, and flame emitted from camera head #2 high voltage supply, which failed, while pt was being scanned. The pt did not suffer any injury. The camera has been repaired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 834398 |
| MDR Report Key | 834398 |
| Date Received | 2007-03-30 |
| Date of Report | 2007-03-29 |
| Date of Event | 2007-03-20 |
| Date Facility Aware | 2007-03-20 |
| Report Date | 2007-03-29 |
| Date Reported to FDA | 2007-03-29 |
| Date Reported to Mfgr | 2007-03-29 |
| Date Added to Maude | 2007-04-05 |
| 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 | 3 |
| 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 | SIEMENS MOLECULAR IMAGING DIVISION |
| Generic Name | E-CAM GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2007-03-30 |
| Model Number | E-CAM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 821721 |
| Manufacturer | * |
| Manufacturer Address | 2501 NORTH BARRINGTON RD HOFFMAN ESTATES IL 60195 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-30 |