MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-08-03 for COHERENCE DOSIMETRIST + ONCOLOIGST WORKSPORE 5856641 7333680 NA manufactured by Siemens Medical Solutions Usa, Inc..
[426931]
An event did not occur, however an intermittent software anomaly has been discovered whereby imported data may be missing after performing a dicom export. The missing data may cause incorrect treatment planning for radiation therapy on third party vendor software.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2910081-2004-00001 |
| MDR Report Key | 618860 |
| Report Source | 07 |
| Date Received | 2004-08-03 |
| Date Mfgr Received | 2004-06-10 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2005-07-05 |
| 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 | KEN NEHMER |
| Manufacturer Street | 4040 NELSON AVE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9252468200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2910081-08/04/04-005C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COHERENCE DOSIMETRIST + ONCOLOIGST WORKSPORE |
| Generic Name | SW OPTION FOR MEDICAL CHARGED-PARTICLE RADIATION THERAPY |
| Product Code | HJW |
| Date Received | 2004-08-03 |
| Model Number | 5856641 7333680 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 608540 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | * CONCORD CA * US |
| Baseline Brand Name | COHERENCE DOSIMETRIST + ONCOLOIGST WORKSPORE |
| Baseline Generic Name | SW OPTION FOR MEDICAL CHARGED-PARTICLE RADIATION THERAPY |
| Baseline Model No | 5856641 7333680 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-03 |