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.
[1063842]
This submittal involves exactly the same issue as reported in submittal 1937649-2009-001. The difference is that it was reported by a different customer at an earlier date.
Patient Sequence No: 1, Text Type: D, B5
[8177148]
When this issue was first reported, cms inc posted a customer bulletin discussing the issue presented in this filing. As noted earlier, at that time we did not consider this to be an mdr situation. With the reoccurrence of the issue even with the bulletin posted for all to read, we now believe it should be reported as an mdr. For a copy of the customer advisory to be sent to all users advising them of the issue presented here, please see 1937649-2009-001. The issue will be corrected in focal release which is currently scheduled to be available in 2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1937649-2009-00002 |
| MDR Report Key | 1352587 |
| Report Source | 05,06 |
| Date Received | 2009-02-11 |
| Date of Report | 2009-02-09 |
| Date of Event | 2007-08-02 |
| Date Mfgr Received | 2007-08-02 |
| Device Manufacturer Date | 2003-11-01 |
| Date Added to Maude | 2009-10-14 |
| 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 |