MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-11-22 for D3112T TUBE NA manufactured by Ge Medical Systems Scs.
[486520]
During a ge warehouse incoming inspection that the hellcoil inserts used to secure the x-ray tube to the gantry was damaged. Engineering investigation determined that the mechanical damage occurred as a result of the tubes being secured to the shipping container using the wrong pitch bolts. As a result, the hellcoils were damaged and their ability to secure the x-ray tube to the gantry structure may be compromised, resulting in the possibiltiy for the x-ray tube to detach from the gantry. It was determined that 26 tubes may be subject to the same issue. A pt was not involved and no incidents, injuries or other adverse affects have been reported as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611343-2005-00039 |
| MDR Report Key | 719438 |
| Report Source | 07 |
| Date Received | 2005-11-22 |
| Date of Report | 2005-11-22 |
| Date of Event | 2005-10-25 |
| Date Mfgr Received | 2005-10-25 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2006-05-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY OVERLAND, PH.D., MGR |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W-400 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482402 |
| Manufacturer G1 | GE MEDICAL SYSTEMS SCS |
| Manufacturer Street | 283, RUE DE LA MINIERE, BP 34 |
| Manufacturer City | BUC CEDEX 78533 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 78533 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D3112T TUBE |
| Generic Name | DIAGNOSTIC X-RAY |
| Product Code | ITY |
| Date Received | 2005-11-22 |
| Model Number | D3112T |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 708506 |
| Manufacturer | GE MEDICAL SYSTEMS SCS |
| Manufacturer Address | 283 RUE DE LA MINIERE BP 34 BUC CEDEX FR 78533 |
| Baseline Brand Name | D3112T TUBE |
| Baseline Generic Name | DIAGNOSTIC X-RAY |
| Baseline Model No | D3112T |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-22 |