MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-09-26 for ULTRANET COLLIMATOR 45296017 NA manufactured by General Electric Co..
[69901]
It was reported to ge that the collimator detached from its mount and fell. Apparently, the mounting screws backed out allowing it to fall. The screws were replaced and secured and the unit placed back in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 57331-1997-00032 |
| MDR Report Key | 122943 |
| Report Source | 05,06 |
| Date Received | 1997-09-26 |
| Date of Report | 1997-09-26 |
| Date of Event | 1997-08-12 |
| Date Mfgr Received | 1997-09-11 |
| Device Manufacturer Date | 1993-09-01 |
| Date Added to Maude | 1997-10-01 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRANET COLLIMATOR |
| Generic Name | DIAGNOSTIC X-RAY |
| Product Code | KPW |
| Date Received | 1997-09-26 |
| Model Number | 45296017 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 120395 |
| Manufacturer | GENERAL ELECTRIC CO. |
| Manufacturer Address | 283 RUE DE LA MINIERE, BP 34 78533 BUE CEDEX, FRANCE FR |
| Baseline Brand Name | ULTRANET COLLIMATOR |
| Baseline Generic Name | DIAGNOSTIC X-RAY |
| Baseline Model No | 45296017 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-09-26 |