Philips has investigated this complaint.According to the additional information collected, the system was not in clinical use when the issue was identified.The philips field service engineer (fse) inspected the device onsite and confirmed that the system was unable to store images.Review of the log file confirmed the reported malfunction with the image processing pc (ip pc).The cause of the ip pc failure was determined to be a hard disk drive issue by the supplier's part analysis.To solve the issue, fse replaced the ip pc, hard disks and loaded software.After the replacement, 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.
|