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 |