MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2006-06-22 for EXACTRAC ROBOTICS, ROBOTIC TILT MODULE 49700 manufactured by Brainlab Ag.
[14868086]
After an upgrade installation of exactrac robotics to an existing novalis system it occurred that after the couch reached its lowest position it faced difficulties moving upwards again under load. During the investigation of this tissue, brainlab became aware that the software limit switch of the couch no longer stops the intended downward motion of the couch. This is an unintended result of the position readout calibration conducted as part of the installation of exactrac robotics on the couch. There has been no patient or user injury, however, a risk to patient health could not be excluded.
Patient Sequence No: 1, Text Type: D, B5
[15390425]
Summary of evaluation: corrective and preventive actions: concerned customers informed via product notification letter. Exactrac robotics will be temporarily removed from its point of use. Provide a permanent solution in cooperation with the radiotherapy couch manufacturer. Re-install the removed exactrac robotics once the permanent solution is available. Add'l catalog number: 49720.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043933-2006-00004 |
| MDR Report Key | 878966 |
| Report Source | 00,05,06 |
| Date Received | 2006-06-22 |
| Date of Report | 2006-05-23 |
| Date Mfgr Received | 2006-05-23 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2007-07-12 |
| 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 | PER PERSSON |
| Manufacturer Street | AMMERTHALSTRASSE 8 |
| Manufacturer City | HEIMSTETTEN 85551 |
| Manufacturer Country | GM |
| Manufacturer Postal | 85551 |
| Manufacturer Phone | 99915680 |
| 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 | EXACTRAC ROBOTICS, ROBOTIC TILT MODULE |
| Generic Name | COUCH, RADIATION THERAPY, POWERED |
| Product Code | JAI |
| Date Received | 2006-06-22 |
| Model Number | EXACTRAC ROBOTICS |
| Catalog Number | 49700 |
| Lot Number | * |
| 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 | 858197 |
| Manufacturer | BRAINLAB AG |
| Manufacturer Address | AMMERTHALSTRASSE 8 HEIMSTETTEN GM 85551 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-22 |