MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-04-13 for CLINAC 2100 C/D * manufactured by Varian Medical Systems.
[21321732]
Investigation found that when the machine was first accepted in march of 2005, it had couch rotation scale (iec601). In september of 2005, a varian field engineer calibrated the couch rotation scale from iec601 to iec1217. The treatment plans and actual plans of the 5 patient's reported by the customer to be mistreated were requested by varian medical systems, but the customer has refused to send detailed info about the patient's. The field service rep was notified of this installation error and has been re-trained. The field service engineer installed the correct couch rotation scale.
Patient Sequence No: 1, Text Type: N, H10
[21581511]
In 2007, the customer reported to a varian field engineer that the couch rotation moves incorrectly when he tried to move the couch rotation with auto set up. The customer reported to varian that most all patient's that have been treated on 0 degree (i. E. The couch rotation angle is the same in both iec601 and iec1217) over the period from 2005 to 2007. There are 5 patient's who received an incorrect dose. Four patient's out of five pt's were treated with whole-brain irradiation and one pt was treated with breast cancer. Varian was informed by the doctor that there probably was no serious injury in association with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2914292-2007-00020 |
| MDR Report Key | 841941 |
| Report Source | 05,06,07 |
| Date Received | 2007-04-13 |
| Date of Report | 2007-02-16 |
| Date of Event | 2007-02-16 |
| Date Mfgr Received | 2007-03-14 |
| Device Manufacturer Date | 2004-12-01 |
| Date Added to Maude | 2007-04-30 |
| 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 | DALE REYNOLDS |
| Manufacturer Street | 911 HANSEN WAY - M/S C-255 |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504246640 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINAC |
| Generic Name | LINEAR ACCELARATOR |
| Product Code | IYG |
| Date Received | 2007-04-13 |
| Model Number | 2100 C/D |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 829212 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | 3100 HANSEN WAY PALO ALTO CA 94304 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-13 |