Philips has investigated this complaint.The philips field service engineer inspected the system onsite and confirmed that the image processing pc (ippc) had malfunction.Review of the system log file showed that there was malfunction with the ippc.Upon troubleshooting, fse found image processor was not functioning correctly.Also found that the host pc was not performing power on self-test to resolve the issue, fse restored power to driveway and host pc, re-created image store.After repairs, the system was returned to use in good working order.At the time this complaint was received, philips did not have enough information to exclude the potential for death or serious injury on recurrence, and as such the complaint was reported.Since that time, it was identified that the issue occurred without patient involvement and was identifiable prior to procedure commencement, which has led to the determination that this is scenario is not likely to cause or contribute to death or serious injury if it were to recur.As per the instructions for use, the user of the product must institute a user routine checks program.The user of the product shall make sure that all checks and actions have been satisfactorily completed before using the product for its intended purpose.It is instructed to not use the product for any application until the user is sure that the user routine checks have been satisfactorily completed, therefore, as the device was outside of use at the time the issue was identified, the user would identify this issue prior to use.Based on re-evaluation, this case is not reportable.The codes were updated based on the investigation outcome.
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