Model Number SCCS1002 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that the sensica device required foam gasket applied to optical sensor as well as a full system re-image and update to the latest software and firmware versions per latest fa action updates as requested by ucc.Also, sensica was detecting tube when no tube was present.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that the sensica device required foam gasket applied to optical sensor as well as a full system re-image and update to the latest software and firmware versions per latest fa action updates as requested by ucc.Also, sensica was detecting tube when no tube was present.
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Search Alerts/Recalls
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