MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-02-11 for FOCAL REL 4.4.1 - 4.40.0 manufactured by Cms Inc.
[1056107]
Dr edits individual mlc leaves in focal after they "snap" the leaves to a patient structure, and then transfers the plan to xio where they open the treatment plan, and place an interest point. When this happens, the leaves return to their original "snapped" positions, removing the dr's edits. All information shown in xio is correct for the shape shown, it is just not what the dr had wanted. No patients have been mistreated.
Patient Sequence No: 1, Text Type: D, B5
[8184393]
Customer advisory will be sent to all users. The issue will be corrected in (b)(4) which is currently scheduled to be available in (b)(4) 2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1937649-2009-00001 |
| MDR Report Key | 1352584 |
| Report Source | 05,06 |
| Date Received | 2009-02-11 |
| Date of Report | 2009-02-09 |
| Date of Event | 2009-02-05 |
| Date Mfgr Received | 2009-02-05 |
| Device Manufacturer Date | 2003-11-01 |
| Date Added to Maude | 2010-01-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PARSONS, ASSOCIATE |
| Manufacturer Street | 13723 RIVERPORT DR. STE 100 |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal | 63043 |
| Manufacturer Phone | 3149930003 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOCAL |
| Generic Name | RADIATION TREATMENT PLANNING WORKSTATION |
| Product Code | KPQ |
| Date Received | 2009-02-11 |
| Model Number | REL 4.4.1 - 4.40.0 |
| Lot Number | A11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CMS INC |
| Manufacturer Address | MARYLAND HEIGHTS MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-11 |