MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-14 for LCV PLUS POSITIONER 2168678-3 NA manufactured by Ge Medical Systems S.c.s..
[20522984]
Unintended motion of gantry. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611343-2005-00023 |
| MDR Report Key | 696258 |
| Report Source | 05 |
| Date Received | 2005-07-14 |
| Date of Report | 2005-07-14 |
| Date of Event | 2005-06-17 |
| Date Mfgr Received | 2005-06-17 |
| Device Manufacturer Date | 1999-10-01 |
| Date Added to Maude | 2006-04-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY OVRLAND, PH.D., MANAGER |
| Manufacturer Street | 300O N. GRANDVIEW BLVD. W-400 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482402 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, S.C.S. |
| Manufacturer Street | 283, RUE DE LA MINIERE BP 34 |
| Manufacturer City | BUC CEDEX 53188 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 53188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LCV PLUS POSITIONER |
| Generic Name | DIAGNOSTIC X-RAY |
| Product Code | LZI |
| Date Received | 2005-07-14 |
| Model Number | 2168678-3 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 685368 |
| Manufacturer | GE MEDICAL SYSTEMS S.C.S. |
| Manufacturer Address | 283 RUE DE LA MINIERE BP 34 BUC CEDEX FR 78633 |
| Baseline Brand Name | LCV PLUS POSITIONER |
| Baseline Generic Name | DIAGNOSIS X-RAY |
| Baseline Model No | 2168678-3 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-14 |