MAUDE Adverse Event Report: BRAINLAB AG EXACTRAC 6.0; PATIENT POSITIONING SYSTEM, RAD. THER.

Model Number 20833B

Device Problems Computer Software Problem (1112); Application Program Problem (2880); Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

When using multiple isocenters (multiple radiation treatment targets) within a single plan, the user detected that, for the second isocenter, exactrac v.6.0.3 positioned the patient to a target different than was planned and intended for radiation treatment at the linear accelerator.There was no misadministration of radiation dose to the patient, since in this specific case the issue was noticed by user before irradiation.According to the hospital, this patient treatment was completed with the correct patient positions applied.

Manufacturer Narrative

There was no misadministration of radiatio dose to the patient, since in this specific case the issue was noticed by user before irradiation.According to the hospital, this patient treatment was completed with the correct patient positions applied.Brainlab conclusion: although there have been no patient injury nor any adverse event reported to brainlab by any hospital regarding this specific issue, a risk to patient health cannot be excluded.When using multiple isocenters (multiple radiation treatment targets) within a single plan, if a specific workflow is used and certain variables relating to software timing and user interaction are met, an anomaly can occur in exactrac v.6.0.3.If this anomaly occurs, exactrac v.6.0.3.Might position the patient to an unintended isocenter position.For further details please refer to the attached product notification letter capa-(b)(4).Brainlab intends the following corrective actions (concluded on (b)(4) 2014): existing potentially affected exatrac 6.0.3 customers receive a product notification information; brainlab will provide a software update with this issue solved to affected customers.Tentative planned timeline for release: end of april 2014.

• Brand Name: EXACTRAC 6.0
• Type of Device: PATIENT POSITIONING SYSTEM, RAD. THER.
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen 8562 2; GM 85622
• Manufacturer Contact: markus hofmann ; kapellenstrasse 12; feldkirchen 85622 ; GM 85622 ; 99915680
• MDR Report Key: 3837555
• MDR Text Key: 22139748
• Report Number: 8043933-2014-00006
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K120789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20833B
• Device Catalogue Number: 49928B
• Device Lot Number: SW VERSION 6.0.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other