Model Number SCCS1002 |
Device Problem
Component Missing (2306)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 05/17/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
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.
|
|
Manufacturer Narrative
|
Upon further review, bd has determined that this mdr was reported in error as this complaint was for an engineering device that will never be customer facing.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.
|
|
Event Description
|
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.
|
|
Search Alerts/Recalls
|