Model Number SCCS1002 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/05/2022 |
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.The device was not returned.
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Event Description
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It was reported that the touch screen did not work on the sensica device.
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Event Description
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It was reported that the touch screen did not work on the sensica device.
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Manufacturer Narrative
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The device was not returned.The reported issue was confirmed to be design related.The root cause of the reported issue is being investigated.The outcome of the repair cannot be determined at this time.The device did not meet specifications and was influenced by the reported failure.It was unknown if the device was in use on a patient.The device history record review was not required as the complaint was addressed by existing capa.Labeling review was not required as the complaint was addressed by existing capa.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 device was not returned.
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Search Alerts/Recalls
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