Model Number SCCS1002 |
Device Problems
Display or Visual Feedback Problem (1184); Operating System Becomes Nonfunctional (2996)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that the sensica unit had a phantom touch that persisted indefinitely which caused other user input to not fully register as the device assumed that the user was touching two separate points on the screen at the same time.The screen was technically responding to the other touches and one button was able to be pressed but not deliberately, and the resulting action could not be undone.
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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.
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Manufacturer Narrative
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The device was not returned.The reported issue was confirmed design related.The root cause of the reported issue is being investigated.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 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.H3 other text : the device was not returned.
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Event Description
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It was reported that the sensica unit had a phantom touch that persisted indefinitely which caused other user input to not fully register as the device assumed that the user was touching two separate points on the screen at the same time.The screen was technically responding to the other touches and one button was able to be pressed but not deliberately, and the resulting action could not be undone.
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Search Alerts/Recalls
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