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Model Number 797403 |
Device Problem
Sharp Edges (4013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: no patient involvement.Blocks b6 & b7: no patient involvement.Block c: not applicable.Block d4: lot# and expiration date are not applicable.Blocks d6, d7, & d10: not applicable; no patient involvement.Blocks h3 & h6: the probable cause of the cracked screen is likely due to damage from use.The device integrity can be affected by external factors such as device manipulation, its impact, and applied pressure associated with use and handling.Blocks h7 & h9: 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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Event Description
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It was reported that the intrasight system's touchscreen monitor was cracked.There was no patient involvement.No user injury reported.At the customer site, a philips field service engineer replaced the 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 has sharp edges that can result in a potential for harm.
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Manufacturer Narrative
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Block e: street address was corrected from (b)(6).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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Search Alerts/Recalls
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