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.
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