MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-02 for * FX-40 #151 manufactured by Smv America.
[57959]
On 6/5/97, while gated stress scans were being obtained, the camera came into contact with pt. Tech immediately attempted to redact camera head. Camera did not redact on command but instead moved closer to pt. Redact command was given again to the camera head went in the opposite direction again which resulted in pinning pt to table. Emergency functions were utilized and procedure discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 103140 |
| MDR Report Key | 103140 |
| Date Received | 1997-07-02 |
| Date of Report | 1997-06-16 |
| Date of Event | 1997-06-05 |
| Date Facility Aware | 1997-06-06 |
| Report Date | 1997-06-16 |
| Date Reported to FDA | 1997-06-20 |
| Date Added to Maude | 1997-07-08 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | * |
| Generic Name | FX-40 W/VISION POWERSTATION & ASPECT IMAGES |
| Product Code | JWM |
| Date Received | 1997-07-02 |
| Model Number | FX-40 #151 |
| Catalog Number | * |
| Lot Number | 3BT |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 10 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 101485 |
| Manufacturer | SMV AMERICA |
| Manufacturer Address | 8380 DARROW RD TWINSBURG OH 44087 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-02 |