MAUDE Adverse Event Report: MOBIUS IMAGING, LLC AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number MOBICT-32

Device Problem Unintended System Motion (1430)

Patient Problem No Information (3190)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

Potential fix and timing: the elmo motion controller configuration was modified to require hall sensors to agree with the motor encoder before allowing motion.This adds a level of redundancy by requiring 5 signals to be in agreement.This change should allow the elmo motion controller to detect an encoder signal fault and put the system in a "safe" (non-moving) state if the tilt drive motor encoder malfunctions; effectively eliminating the chance of harm occurring from unintended motion of the gantry.Mobius imaging is currently working on the update to the motion controller configuration settings.The new version of the tilt-drive motion controller configuration settings should be available for airo systems by the end of september 2017.Brainlab will actively contact affected customers immediately to schedule the installation of the update.Mobius imaging believes, due to an issue with the configuration settings of the tilt-drive motion controller, if a tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended tilt motion of gantry while airo system is homing the axis at startup or preparing for a scan.Since the airo is not currently monitoring for intermittent connections or broken tilt-drive motor wires, if a wire breaks or the signal becomes intermittent the tilt-drive motor would not get the correct feedback and the motor could behave unpredictably.If a tilt-drive motor wire breaks or the signal becomes intermittent the following behaviors could be seen in the airo: when pushing the green button to home/tilt the gantry, the gantry may tilt in either direction, and at a higher than normal speed.A test fixture was added to a system in-house to introduce an intermittent failure of the different motor and encoder wires, and the unintended motion of the gantry was replicated.The elmo motion controller configuration was modified to require hall sensors to agree with the motor encoder before allowing motion.This adds a level of redundancy by requiring 5 signals to be in agreement.This change should allow the elmo motion controller to detect an encoder signal fault and put the system in a "safe" (non-moving) state if the tilt drive motor encoder malfunctions.Verification testing was performed and the update worked as intended.The firmware update mitigates the risks associated with this failure mode.Investigation of the exact root cause is still on-going.The ct technician/operator running the system will know if the gantry tilts, however the operator may not be able to respond (by releasing green button or pressing the emergency stop button) in time to prevent harm.There have been no injuries reported related to this issue.Conclusion: this issue was determined to be a class i recall, requiring immediate notification to all customers/users, fda, and row authorities.

Event Description

Risk of unintended tilt motion of gantry while airo system is homing the axis at startup or preparing for a scan.

• Brand Name: AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): MOBIUS IMAGING, LLC; 2 shaker road; suite f100; shirley MA 01464
• Manufacturer (Section G): MOBIUS IMAGING, LLC; 2 shaker road; suite f100; shirley MA 01464
• Manufacturer Contact: michael flynn ; 2 shaker road; suite f100; shirley, MA 01464
• MDR Report Key: 8283370
• MDR Text Key: 136745845
• Report Number: 3010151377-2017-00006
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MOBICT-32
• Device Catalogue Number: MOBICT-32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3010151377-9/26/2017-C
• Patient Sequence Number: 1