This case was reviewed and investigated according to the manufacturer¿s policy.Pt.Info: no patient involvement.Relevant tests/alb data & other relevant history: no patient involvement.Suspect product: not applicable.Lot# and expiration date are not applicable.Implant/explant dates, & concomitant medical products: not applicable; no patient involvement.The probable cause of the cracked screen is likely due to physical damage.The device integrity can be affected by external factors such as device manipulation, its impact, and applied pressure associated with use and handling.If remedial action initiated, check type & correction/removal number: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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It was reported that the intrasight system''s touchscreen monitor was cracked.There was no patient involvement.No user injury was reported.At the customer site, a philips field service engineer replaced the intrasight system's cracked touchscreen monitor and confirmed operation.The touchscreen monitor was returned for evaluation.Visual inspection found cracks and missing screen material, resulting in sharp edges.This product problem is being reported in an abundance of caution because the touchscreen monitor was cracked with sharp edges that can result in a potential for harm.
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