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Model Number 797411 |
Device Problem
Sharp Edges (4013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This case was reviewed and investigated according to the manufacture¿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 touchscreen monitor was not returned for evaluation, thus no returned product investigation was performed.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 core m2 vascular system touchscreen monitor is cracked with sharp edges observed.There was no patient present and no user injury reported.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 h3: the touchscreen monitor was returned for evaluation.Visual inspection confirmed a crack, resulting in sharp edges.Block h6: based on the returned screen, the probable cause is likely due to unexpected 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.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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