MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-30 for VISION DS7 70020007 manufactured by Smv America.
[86865]
An nmt was setting up for a tomo study. The detector (radius) moved too close to the pt, pressing against his arm, but he was not hurt. Nmt hit the emergency stop switch in time. At the time, no safety pad was on the detector. Customer knows better now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528274-1998-00003 |
| MDR Report Key | 146508 |
| Date Received | 1998-01-30 |
| Date of Report | 1998-01-30 |
| Date of Event | 1998-01-26 |
| Date Facility Aware | 1998-01-26 |
| Report Date | 1998-01-30 |
| Date Reported to FDA | 1998-01-30 |
| Date Reported to Mfgr | 1998-01-30 |
| Date Added to Maude | 1998-02-03 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 DS7 |
| Generic Name | CAMERA |
| Product Code | JWM |
| Date Received | 1998-01-30 |
| Model Number | DS7 |
| Catalog Number | 70020007 |
| Lot Number | S/W 3.14 R3 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 142792 |
| Manufacturer | SMV AMERICA |
| Manufacturer Address | 8380 DARROW ROAD TWINSBURG OH 44087 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-30 |