Philips has investigated this complaint.The customer reported to philips that the patient suffered from suspected radiation burn on his back.Philips was informed that the patient had a pre-existing condition of hepatitis b, liver cirrhosis, liver cancer.However, the customer has not provided the requested additional information regarding the reported incident and the patient outcome despite good faith effort performed by philips.The customer did not allow onsite inspection of the system by philips.System log files and dose reports were also not provided by the customer.Based on the limited information available, philips has not been able to identify or confirm the root cause of the issue.The customer stated that the philips system did not malfunction.Based on this statement of the customer, philips has closed this complaint.Correction of initial report text in section b5, section h6, method code was changed as the device was not available for investigation.Section d2 common device name was corrected to interventional fluoroscopic x ray system.Section e1 address has been changed.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text : the customer did not allow onsite inspection of the system by philips.System log files and dose reports were also not provided by the customer.
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