MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-05 for VISION POWERSTATION VISON POWERSTATION FP 201 manufactured by Smv America.
[36041]
After mibi myocard reconstruction, the customer thinks that there is a difference between the both reconstructed volumes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528274-1996-00025 |
| MDR Report Key | 54222 |
| Date Received | 1996-12-05 |
| Date of Report | 1996-11-26 |
| Date of Event | 1996-09-27 |
| Date Facility Aware | 1996-10-18 |
| Report Date | 1996-11-26 |
| Date Reported to Mfgr | 1996-11-26 |
| Date Added to Maude | 1996-12-10 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | VISION POWERSTATION |
| Generic Name | COMPUTER |
| Product Code | JWM |
| Date Received | 1996-12-05 |
| Model Number | VISON POWERSTATION |
| Catalog Number | FP 201 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 54794 |
| Manufacturer | SMV AMERICA |
| Manufacturer Address | 8380 DARROW RD TWINSBURG OH 44087 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-05 |