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 Image Display Error/Artifact (1304)

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

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

An intermittent signal from one of the system das boards was causing pixels in the ct image to become dark, which caused an image artifact in two slices of the reconstruction of the ct image.The artifact was immediately identifiable to the operator as a system issue/malfunction rather than an actual patient anatomical anomaly.The intermittent pixel was "mapped out" by a service technician and the system performed as intended.This case was initially determined to be non-reportable by the manufacturer because there was no report of injuries and the risk of harm to patients if this was to reoccur was determined to be remote / not likely to contribute to a death or serious injury.This case is being reported at this time because during a fda inspection in april of 2018 this case was specified in a fda-483 as being a reportable event.

Event Description

Image artifact identified by user in a patient scan.No additional scans of the patient were required; and no injuries reported.

• 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: 8283345
• MDR Text Key: 136610467
• Report Number: 3010151377-2018-00002
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/31/2018

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?: 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• 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): Required Intervention