MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-02-03 for LCA POSITIONER 2168677 NA manufactured by Ge Medical Systems Europe.
[21393394]
When tech performed a system reset, the image intensifier (on c-arm) moved at a fast speed until it contacted the mechanical hard stop. This movement is not expected at system reset. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615767-2004-00002 |
| MDR Report Key | 521326 |
| Report Source | 05,06 |
| Date Received | 2004-02-03 |
| Date of Report | 2004-02-03 |
| Date of Event | 2003-11-30 |
| Date Mfgr Received | 2003-11-30 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 2004-04-21 |
| 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 EUROPE |
| 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LCA POSITIONER |
| Generic Name | DIAGNOSTIC X-RAY |
| Product Code | LCI |
| Date Received | 2004-02-03 |
| Model Number | 2168677 |
| Catalog Number | NA |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 510434 |
| Manufacturer | GE MEDICAL SYSTEMS EUROPE |
| Manufacturer Address | 283, RUE DE LA MINIERE, BP 34 BUC CEDEX FR 78533 |
| Baseline Brand Name | LCA POSITIONER |
| Baseline Generic Name | DIAGNOSTIC X-RAY |
| Baseline Model No | 2168677 |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-03 |