MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-01-30 for SOLARIX TUBE/BUCKY STAND 10925A NA manufactured by Ge Medical Systems Europe.
[43870]
It was reported to co that the tube/bucky support cables failed allowing the tube/bucky arm assembly to fall. The device was repaired and placed back in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 57331-1997-00002 |
| MDR Report Key | 66902 |
| Report Source | 05,06 |
| Date Received | 1997-01-30 |
| Date of Report | 1997-01-30 |
| Date of Event | 1997-01-27 |
| Date Mfgr Received | 1997-01-27 |
| Device Manufacturer Date | 1982-11-01 |
| Date Added to Maude | 1997-02-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLARIX TUBE/BUCKY STAND |
| Generic Name | DIAGNOSTIC X-RAY |
| Product Code | ITY |
| Date Received | 1997-01-30 |
| Model Number | 10925A |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 66958 |
| Manufacturer | GE MEDICAL SYSTEMS EUROPE |
| Manufacturer Address | 283, RUE DE LA MINIERE, BP 34 BUC CEDEX FR 78533 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-30 |