MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-17 for PROTURA ROBOTIC COUCHTOP MT6X300TE manufactured by Medtec, Inc., Dba. Civco Medical Solutions.
[58195564]
Facility did not return device. Movement logs were evaluated. Device was not returned for eval. Facility movement logs were returned and evaluated to confirm the table movement. Facility acknowledges they activated the device by accident. Results: customers activated the device by accident and moved pt during treatment. Analysis by facility is there are not significant clinical consequences from this treatment error. Conclusion: based on the event and the user facility acknowledgement, they activated the move of the table which caused the mistreatment, this is identified as a user error. There is no clinical consequence from the treatment error and the pt will continue with the original treatment plan. The worst case scenario was simulated by assuming the entire first fraction was treated incorrectly. A sum plan of 1 incorrect treatment and 32 correct treatments was performed by one of our physicists, and reviewed by 2 clinicians. Although there was a slightly lower dose in the ptv region and slightly higher dose to the intracranial structures, their conclusion was there was no significant clinical consequence from this treatment error. No change has been made to the treatment plan and the pt will continue treatment with the original treatment plan.
Patient Sequence No: 1, Text Type: N, H10
[58195565]
This occurred on the first fraction of the pt's treatment. The protura table was lowered for the previous pt that was treated due to him having an extended ssd (source to surface distance). The facility forgot to put the protura table back to the zero position for the current pt's treatment. The kv images were taken and they proceeded with the treatment as normal. As the facility had not used the protura table for some time the computer screen went to sleep. After taking the kv images the therapist moved the mouse of the protura computer as it was off so they could prepare for the next pt. It seems when the computer was woken up the therapist accidentally triggered the table to move to the zero position. This was during the current pt's treatment and the therapist did not notice the protura table moving. The incident resulted to a 5cm vertical shift. The pt gets 33 fractions, with a dose per fraction of 2. 11 gy. The facility activated the movement by accidentally clicking the zero button during treatment because their computer system went into sleep mode. To prevent this accidental movement, civco has conducted an add'l training session with the facility and provided the add'l ways in which to prevent this from occurring. The following actions are alternative approaches to using the equipment which can be used by the facility to keep from activating the load/unload or zero button by accident. Changing the 'monitor to sleep' mode to never, shutting the power off on the protura when they are not using it, shutting down the software when not using it to position pts, creating and loading a pt profile for every pt and if no moves are needed clicking move with 0 as shift values and getting to the lockout window, creating a 'dummy' pt that they use for all pts that are not being positioned with protura and staying on the lockout window with 0 as the shift value (similar to last option. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932738-2012-00001 |
| MDR Report Key | 2805573 |
| Date Received | 2012-10-17 |
| Date of Report | 2012-10-17 |
| Date of Event | 2012-09-17 |
| Date Mfgr Received | 2012-09-17 |
| Device Manufacturer Date | 2011-12-12 |
| Date Added to Maude | 2012-10-26 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1401 8TH ST. S.E. |
| Manufacturer City | ORANGE CITY IA 51041 |
| Manufacturer Country | US |
| Manufacturer Postal | 51041 |
| Manufacturer Phone | 8008428688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROTURA ROBOTIC COUCHTOP |
| Generic Name | PROTURA ROBOTIC COUCHING |
| Product Code | JAI |
| Date Received | 2012-10-17 |
| Model Number | MT6X300TE |
| Catalog Number | MT6X300TE |
| Lot Number | M813710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTEC, INC., DBA. CIVCO MEDICAL SOLUTIONS |
| Manufacturer Address | 1401 8TH ST. S.E. ORANGE CITY IA 51041 US 51041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-17 |