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 01/31/2023 |
Event Type
malfunction
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Event Description
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It was reported that a tube sensor left entry reads ¿open¿ when bag tube was not attached, ensured the ¿tube sensor left¿ entry reads ¿actuated¿ after bag tube was connected to the sensica device.A message had been received could be seen on rss portal under device status.The device failed tube sensor left and once actuated and tube was removed, it stated actuated and never returns to open.
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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.The device was not returned.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as there was no allegation against the product.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 a tube sensor left entry reads ¿open¿ when bag tube was not attached, ensured the ¿tube sensor left¿ entry reads ¿actuated¿ after bag tube was connected to the sensica device.A message had been received could be seen on rss portal under device status.The device failed tube sensor left and once actuated and tube was removed, it stated actuated and never returns to open.
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Search Alerts/Recalls
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