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

Model Number	MOBICT-32
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Machine was warmed up and the bed was functioning.Patient was put to sleep and positioned on the airo table.Hip pins were placed, ct was called for the spin.The scout was taken followed by the scan.After the scan was taken, the images would not send and the airo just kept spinning and shut off.Stryker navigation rep called the airo rep and was instructed to call the stryker airo support number.Trouble shooting was unsuccessful.Case was canceled.No incision was made.Patient was extubated and sent to pacu.Upon investigation found battery number 2 to be inoperative.The device has a control panel which indicates "power" and "battery charging" on the lower left of the screen but it cannot tell the charge capacity of the individual batteries to know that they will retain the charge when it is unplugged.

• Brand Name: AIRO COMPUTED TOMOGRAPHY (CT) X
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): MOBIUS IMAGING LLC.; shirley MA 01461
• MDR Report Key: 17452484
• Report Number: MW5120532
• Device Sequence Number: 16822204
• Product Code: JAK
• UDI-Device Identifier: 00869346000200
• UDI-Public: 00869346000200
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: MOBICT-32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White