MAUDE Adverse Event Report: BRILLIANCE AIR 40/64/UCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	728323
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr#(b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was that gantry mylar ring broke and made contact with the patient in the face and elbow.Based on the available information, this issue has been initially determined to be a reportable event.
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was that gantry mylar ring broke and made contact with the patient in the face and elbow.Based on the information, this issue has been determined to be a reportable event.
Additional Manufacturer Narrative
The issue reported was that the mylar ring (also called lexan ring) broke into multiple pieces during gantry rotation and hit the patient in the face and elbow.The philips field service engineer (fse), confirmed the patient received a minor cut to the arm.Multiple attempts were made to determine if the patient received medical care.However, this information was not provided.The fse reported to the site and evaluated the system.It was confirmed that a crack existed on the mylar ring prior to it breaking.This was evaluated by the service team, but, the customer declined service and decided to use the system as it was.The existing crack was not fixed until the parts on the gantry rotor (reference detector bracket) hit and broke the mylar ring.To resolve the issue, the fse replaced the mylar (lexan ring) and the reference detector bracket.Engineering reviewed the details and post market data associated with this event and concluded this event as a single fault due to customer abnormal use.This is not a systemic issue philips healthcare products are designed to meet stringent safety standards, and, the system shall not be used, if any part of the equipment or system is known (or suspected) to be operating improperly.Users should follow the safety warnings and guidelines described in the instructions for use (ifu), qrg (quick reference guide), and trg (technical reference guide).It is vital that the users strictly follow all safety directions to ensure the safety of both patients and operators.The probable cause was use error in using the system with a known damaged mylar/lexan ring.Internal cross reference: complaint (b)(4).Health impact code: c172008- a mild injury, illness or impairment which can be treated with minimal or no intervention.

• Brand Name: BRILLIANCE AIR 40/64/UCT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11676277
• Report Number: 3015777306-2021-10003
• Device Sequence Number: 14509251
• Product Code: JAK
• UDI-Device Identifier: 00884838059504
• UDI-Public: 00884838059504
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 728323
• Device Catalogue Number: 728323
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/18/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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