MalfunctionEXS

SENSICA UO MONITOR ICU

Received Jun 11, 2023 · Event occurred May 17, 2023

Report 1018233-2023-04185 · MDR key 17102410

Device

Generic name

Sensica Device

Manufacturer

C.r. Bard, Inc. (covington) -1018233

Model number

SCCS1002

Catalog number

SCCS1002

Lot number

Product problems

Component Missing
Component Missing

Patient

Unknown

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Additional 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.

Description of Event or Problem

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.

Additional 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.

Description of Event or Problem