MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-08-28 for ACQPLAN 5.0 * manufactured by Philips Medical Systems.
[17484442]
Incident involved radiation dose planning, an error in calculation occurred. Because the error was quite obvious the treatment was not delivered as planned. An original plan was done and calculated correctly, an option to copy the plan was utilized, and the area of calculation was modified. The resulting dose displayed showed areas of dose outside the treatment field, which prompted the physicist to question the dose. A workaround was used, that resulted in the properly displayed dose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525965-2003-00009 |
| MDR Report Key | 481485 |
| Report Source | 05,06 |
| Date Received | 2003-08-28 |
| Date of Report | 2003-08-01 |
| Date of Event | 2003-08-01 |
| Date Mfgr Received | 2003-08-01 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2003-09-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL HAYES |
| Manufacturer Street | 595 MINER ROAD |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404833521 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 595 MINER ROAD |
| Manufacturer City | CLEVELAND OH 41143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 41143 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACQPLAN 5.0 |
| Generic Name | MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2003-08-28 |
| Model Number | ACQPLAN |
| Catalog Number | * |
| Lot Number | * |
| ID Number | SOFTWARE VERSION 4.9 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 470374 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 595 MINER RD. CLEVELAND OH 44143 US |
| Baseline Brand Name | ACQPLAN 5.0 |
| Baseline Generic Name | MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM |
| Baseline Model No | ACQPLAN |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | ACQPLAN |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K013644 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-08-28 |