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 Patient Involvement (2645)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

The issue with the main-drive motor is a risk in transport mode only (while driving and/or transporting the system).There are no additional risks associated with this issue in scan mode (during clinical use with a patient).If the fault occurs, it is immediately identifiable by the operator.There have been no injuries reported (to date) related to this issue.System breaking/stopping mechanisms are unaffected by the fault, and the operator can quickly stop all system motion by hitting the emergency stop button.Investigation results: due to an issue with the configuration settings of the main-drive motion controller, if a main-drive motor has a broken encoder or sensor wire there is a risk of unintended motion while driving or transporting the airo system.The routing of the main-drive motor cable can cause long-term repeated bending & flexing of the cable and possible breakage of the motor wire(s) while the system goes into / out of transport mode and while driving or transporting the system.Since the airo is not currently monitoring for broken main-drive motor wires, if a wire breaks the main-drive motor would not get the correct feedback and the motor could behave unpredictably.If a main-drive motor wire breaks, the following behaviors could be seen in the airo: when pushing the "forward" or "reverse" driving buttons while in transport mode, the system could respond/move in the opposite direction, when driving or transporting the system, the driving speed could change unexpectedly (increase up to 2 mph or decrease), when starting to drive or transport the system, the acceleration rate could change unexpectedly (system could lurch forward/back or slow down), while driving or transporting the system, the main-drive motor could stop unexpectedly.Corrective actions: as a result of this malfunction, a capa has been opened to document investigation and corrective actions.The motion controller firmware will be updated on all systems to enable broken wire detection in the main drive, which will eliminate the risk of unintended motion.Any new information will be provided in a follow-up report.Note: complaint was initially classified as non-reportable.When additional complaints from different sites were received, all similar complaints were reexamined and this case was then determined to be related and reportable.

Event Description

Airo unable to transport using the pendant buttons.

• 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 ; 9787965068
• MDR Report Key: 8282547
• MDR Text Key: 136610220
• Report Number: 3010151377-2017-00003
• 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,user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3010151377-7/20/17-001-C
• Patient Sequence Number: 1