The issue reported was that while positioning an unconscious patient, the customer did not support/restrain the patient's arms, and they bumped/fell against the gantry mylar ring.This led to the mylar ring being damaged, which caused a laceration to the patient's arm requiring stitches.The system was in clinical use when this occurred.The philips field service engineer (fse) went on site to evaluate and confirm the reported issue.The fse confirmed that the patient was unconscious and had moved randomly when being positioned on the scanning couch.The patient bumped his arm against the gantry mylar ring, which led to the mylar ring damage and patient's arm injury.The fse reported that the patient wound was about 3-5 centimeters long and 0.3 centimeters deep.When this occurred, the customer pressed the e-stop (emergency stop) button and stopped clinical use of the system.The patient's arm injury was treated with stitches.Philips engineering reviewed the details of the event and concluded that there was no malfunction of the system, this was use error of not making sure the patient¿s arms were strapped/supported securely on the table.The operator is to ensure that the patient is placed and strapped securely on the patient table and to keep the patient under continuous observation during all movements of the gantry and the patient table.The probable cause was use error in not securely strapping/supporting the unconscious patient¿s arms.Internal cross reference: complaint pr# (b)(4).Health impact code: (b)(4); a severe injury, illness or impairment which requires hospitalization or medical intervention.Date of report: 20210823.
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This complaint has been evaluated based on the information provided.The issue reported was that while positioning an unconscious patient, the patient's arm was not secured and bumped against the gantry mylar ring.This led to the mylar ring being damaged causing a laceration to patient's arm injury which required stitches.There was no malfunction of the system; it is working as specified.Based on the available information, this issue has been determined to be a reportable event.
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