MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-11-05 for RAD MICRO 80 HF * manufactured by Fischer Imaging Corp..
[331231]
After completing the necessary views on the patient abnormal noises were heard coming from the product and shortly thereafter smoke was seen coming from the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418957-2003-00004 |
| MDR Report Key | 494763 |
| Report Source | 06 |
| Date Received | 2003-11-05 |
| Date of Report | 2003-10-31 |
| Date of Event | 2003-09-24 |
| Date Mfgr Received | 2003-10-03 |
| Device Manufacturer Date | 1992-01-01 |
| Date Added to Maude | 2003-11-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | GARY TURNER |
| Manufacturer Street | 12300 NORTH GRANT STREET |
| Manufacturer City | DENVER CO 80241 |
| Manufacturer Country | US |
| Manufacturer Postal | 80241 |
| Manufacturer Phone | 3032542525 |
| Manufacturer G1 | FISCHER IMAGING CORPORATION |
| Manufacturer Street | 12300 NORTH GRANT STREET |
| Manufacturer City | DENVER CO 80241 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80241 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAD MICRO 80 HF |
| Generic Name | X-RAY MACHINE |
| Product Code | IYB |
| Date Received | 2003-11-05 |
| Model Number | RAD MICRO 80 HF |
| Catalog Number | * |
| Lot Number | * |
| ID Number | SITE CODE TAG: P96840411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 483478 |
| Manufacturer | FISCHER IMAGING CORP. |
| Manufacturer Address | 12300 NORTH GRANT ST. DENVER CO 80241 US |
| Baseline Brand Name | RAD MICRO 80 HF |
| Baseline Generic Name | X-RAY MACHINE |
| Baseline Model No | RAD MICRO 80 HF |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-05 |