MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-07-30 for EXACTRAC INFRARED TRACKING PLATFORM 5.0, 5.5 5.0,5.5 49900B, 49900C manufactured by Brainlab Ag.
[903595]
During set-up of the patient with the exactrac auto-positioning process, the user recognized while visually monitoring the patient that the couch continued driving beyond the planned treatment position. The operator released the motion enable keys to stop the couch movement. There has been no patient or user injury reported by any hospital however under the observed rare circumstances a risk to patient health could not be excluded. The root cause and the according corrective action decision from brainlab's investigation was concluded on july 17,2008.
Patient Sequence No: 1, Text Type: D, B5
[8110374]
There has been no patient or user injury reported by this or any other hospital however a risk to patient health could not be excluded. Summary of evaluation: this potential problem could be reproduced at brainlab using the same sw versions of exactrac as the initial reporter. Corrective and preventive action. - product notification- existing exactrac customers will receive a product notification information. - brainlab will provide a software update for the affected exactrac 5. 0. 2 and 5. 5. 1 customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043933-2008-00004 |
| MDR Report Key | 1084549 |
| Report Source | 07 |
| Date Received | 2008-07-30 |
| Date of Report | 2008-07-30 |
| Date of Event | 2008-05-05 |
| Date Mfgr Received | 2008-05-05 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2009-05-06 |
| 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 | MARKUS HOFMANN |
| Manufacturer Street | KAPELLENSTRASSE 12 |
| Manufacturer City | FELDKIRCHEN 85622 |
| Manufacturer Country | GM |
| Manufacturer Postal | 85622 |
| Manufacturer Phone | 99915680 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXACTRAC INFRARED TRACKING PLATFORM 5.0, 5.5 |
| Generic Name | EXACTRAC |
| Product Code | IXG |
| Date Received | 2008-07-30 |
| Model Number | 5.0,5.5 |
| Catalog Number | 49900B, 49900C |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAINLAB AG |
| Manufacturer Address | KAPELLENSTRASSE 12 FELDKIRCHEN 85622 GM 85622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-30 |