MAUDE Adverse Event Report: AIRO CT SCANNER; AIRO MOBILE CT SYSTEM

Model Number	MOBICT-32
Medical Device Problem Codes	Positioning Failure (1158); Unintended Collision (1429); Device Handling Problem (3265)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	12/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On 01/04/2020, it was reported to technical support that when moving the airo out of the operating room, the nurse crashed the airo into the wall, resulting in the nurses' hand being crushed.It was reported after routine follow-up that the nurse was holding the pendant holster attempting to move the airo backwards and there was no clear path in the hallway making it difficult to position the airo.When moving the airo the nurses left thumb got stuck between the airo and the operating room door resulting in the user injury.There was medical intervention and the result of the emergency room visit was the amputation of the nurses distal phalanx.Additional information was requested.
Event or Problem Description
It was reported that, while transporting the airo ct scanner, a nurse experienced a crushing injury which resulted in the amputation of their left thumb.The airo system was positioned with the pendant facing the operating room and the nurse was holding the pendant holster to move the airo system backward with the pendant in the holster during transport.There was material in the hallway, making it difficult to turn the machine around and drive forward.The nurse had difficulty maneuvering the airo and crushed their hand between the device and the operating room doorway.The nurse was taken to the emergency room by a colleague and received treatment for their injury, resulting in the amputation of the left thumb.
Additional Manufacturer Narrative
Manufacturing records for this device and complaint history for all airo units received since the manufacturing of this device were reviewed no relevant issues or similar complaints were identified.Examination of the device in the field confirmed that there was no malfunction at the time of the event.Additional investigation confirmed that the individual who was injured was not trained in accordance with stryker airo operating requirements.During installation of the airo, users are required to attend formal training prior to using the device.Formal airo training provides evidence for safe use and is provided through stryker representatives or authorized parties.In this case, the user was trained by internal hospital staff and did not received the necessary formal training.The investigation has concluded there was no malfunction of the airo and that the incident was due to operator lack of training.

• Brand Name: AIRO CT SCANNER
• Common Device Name: AIRO MOBILE CT SYSTEM
• MDR Report Key: 11214835
• Report Number: 3010151377-2021-00001
• Device Sequence Number: 14274286
• Product Code: JAK
• UDI-Device Identifier: 00869346000200
• UDI-Public: 00869346000200
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021
• Report Date (Section F): 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MOBICT-32
• Device Catalogue Number: MOBICT-32
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other