MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-05-17 for FOCUS 9200 * manufactured by Computerized Medical Systems.
[247509]
Customer reported that the imrt mlc modulation factor and monitor units appear to be calculated incorrectly for vanan mlc's. The problem occurs in termittenly. No patients were treated using the incorrect values.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937649-2002-00009 |
| MDR Report Key | 395510 |
| Report Source | 05,06 |
| Date Received | 2002-05-17 |
| Date of Report | 2002-05-16 |
| Date of Event | 2002-04-16 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2002-05-23 |
| 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 | 0 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DIRECTOR |
| Manufacturer Street | 1145 CORPORATE LAKE DRIVE |
| Manufacturer City | ST. LOUIS MO 63132 |
| Manufacturer Country | US |
| Manufacturer Postal | 63132 |
| Manufacturer Phone | 3149930003 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOCUS |
| Generic Name | RADIATION TREATMENT PLANNING SYSTEM |
| Product Code | MWJ |
| Date Received | 2002-05-17 |
| Model Number | 9200 |
| Catalog Number | * |
| Lot Number | RELEASE 3.2.1 |
| 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 | 384516 |
| Manufacturer | COMPUTERIZED MEDICAL SYSTEMS |
| Manufacturer Address | 1145 CORPORATE LAKE DR. ST. LOUIS MO 63132 US |
| Baseline Brand Name | FOCUS RADIATION TREATMENT PLANNING SYSTEM |
| Baseline Generic Name | RTP: SYSTEM |
| Baseline Model No | 9200 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-05-17 |