Catalog Number SCCS1002 |
Device Problems
Defective Component (2292); Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
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 urine output system touchscreen need update and failed bcm during calibration.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause of the reported issue was a failed bcm.A dhr is not required as this is event not an out-of-box failure and therefore is not manufacturing related.The reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.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.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that the sensica urine output system touchscreen need update and failed bcm during calibration.
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Search Alerts/Recalls
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