MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-12-16 for AW ADVANTAGE SIM MD 5160092-2 manufactured by Ge Medical Systems S.c.s.
[1012767]
It was reported that when using advantage sim md and selecting multiple series, there was a mismatch of series label that occurred for structure sets between the image view and user interface. Some structure sets generated cannot be read by treatment planning system at the site. There has been no injury reported due to this issue. However, if inconsistent series labels are not detected, this issue can lead to potential inadequate treatment of tumors.
Patient Sequence No: 1, Text Type: D, B5
[8136840]
The alleged mismatch was confirmed between the voxtool view (vv) or image view and the user interface (ui) on the left panel during an on-site visit by ge clinical applications. Further investigation revealed series label on the ui remained correct and matched the series number. The vv showed correct series number but incorrect series label. It was found that incorrect labeling occurs when multiple series (non-4d images) of the same exam with different series dates were selected and loaded simultaneously in advantage sim md. Since the ui with vv are not synchronized and have different sorting mechanisms during multiple selection, a mismatch develops between the two when the conditions mentioned are met. The issue was found reproducible in-house during engineering investigation. Clinical analysis further determined that the issue is not immediately obvious to the users.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611343-2008-00065 |
| MDR Report Key | 1265721 |
| Report Source | 06 |
| Date Received | 2008-12-16 |
| Date of Report | 2008-05-27 |
| Date of Event | 2008-05-27 |
| Date Mfgr Received | 2008-11-28 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2010-02-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTHA KAMROW |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | GE MEDICAL SYSTEMS S.C.S. |
| Manufacturer Street | 283 RUE DE LA MINIERE, BP-34 |
| Manufacturer City | BUC CEDEX 78533 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 78533 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AW ADVANTAGE SIM MD |
| Product Code | KPQ |
| Date Received | 2008-12-16 |
| Model Number | 5160092-2 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS S.C.S |
| Manufacturer Address | 283 RUE DE LA MINIERE BP 34 BUC CEDEX 78533 FR 78533 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-16 |