The patient was treated on (b)(6) 2017.The system is under service contract with a philips distributor in (b)(4).The distributor has provided philips with all available service reports, performed tests and information from the field service engineer (fse) who checked the system on site.The distributor¿s fse confirmed that he tested the system on 2017aug19 and the outcome showed that the system was working within specifications except for the grid switch test which failed.In the presence of a grid switch failure the system will ensure that the entrance dose rate will be reduced and that the issue will not result in increased dose for the patient.According to the distributor¿s fse the customer was aware about the grid switch error.To correct this, the tube needs to be replaced.As far as we know, customer has not replaced it.The available system test results and other information was analyzed by a philips igt product designer who concluded that the system is working within specification and all necessary calibrations were performed and passed for all dose relevant tests.Not enough information has been provided to estimate or calculate the dose received by the patient, and if the dose received is related to the skin burn reported by the customer.Based on the information provided, no malfunction of the system has been confirmed that could have led to the skin burn reported.Therefore , no further actions will be taken by philips.
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