SENSICA UO ICU MONITOR
Received Jul 21, 2022 · Event occurred Jan 27, 2022
Report 1018233-2022-05670 · MDR key 15075503
Device
Generic name
Sensica Uo Icu Monitor
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Display or Visual Feedback Problem
- Display or Visual Feedback Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA DEVICE WAS EXHIBITING PHANTOM TOUCHES, SPECIFICALLY CLICKING ON THE SHUTDOWN AND ACTIONS KEY REPEATEDLY. THE UNIT WAS STILL FUNCTIONAL BECAUSE THE PHANTOM TOUCHES WERE INTERMITTENT. REPRESENTATIVE ASKED THE NURSE TO CLEAN THE SCREEN, WHICH DID NOT SOLVE THE ISSUE. THEN THE REPRESENTATIVE RESTARTED THE UNIT BY ATTACHING AND DETACHING THE RING, WHICH CAUSED A REBOOT THAT ELIMINATED THE PHANTOM TOUCH ISSUE AND SENT THE UNIT BACK INTO THE PATIENT MONITORING SCREEN. THE UNIT WAS FUNCTIONING NORMALLY.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED DESIGN RELATED. THE UNIT WAS STILL FUNCTIONAL BECAUSE THE PHANTOM TOUCHES WERE INTERMITTENT. REPRESENTATIVE ASKED THE NURSE TO CLEAN THE SCREEN, WHICH DID NOT SOLVE THE ISSUE. THEN THE REPRESENTATIVE RESTARTED THE UNIT BY ATTACHING AND UNATTACHING THE RING, WHICH CAUSED A REBOOT THAT ELIMINATED THE PHANTOM TOUCH ISSUE AND SENT THE UNIT BACK INTO THE PATIENT MONITORING SCREEN. THE UNIT WAS FUNCTIONING NORMALLY. ALL GOOD FAITH ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. THE OUTCOME OF THE REPAIR CANNOT BE DETERMINED AT THIS TIME. IN THE EVENT THAT INFORMATION REGARDING THE OUTCOME OF THE REPAIR AND THE STATUS OF THE DEVICE IS RECEIVED, THIS RECORD WILL BE REOPENED TO UPDATE THE INVESTIGATION. THE FOLLOWING ROOT CAUSES/CONTRIBUTING FACTORS WERE IDENTIFIED: FIRMWARE ¿ ROOT CAUSE. CLEANING AGENTS ¿ CONTRIBUTING FACTOR. CUSTOMER IFU OVERSIGHTS ¿ CONTRIBUTING FACTOR. COVID ERA ¿ CONTRIBUTING FACTOR. IFU NOT IN ALIGNMENT WITH CLEANING VALIDATION ¿ CONTRIBUTING FACTOR. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: DO NOT STERILIZE ANY COMPONENT OF THE BD SENSICA¿ URINE OUTPUT SYSTEM. TO CLEAN THE DISPLAY TOUCH SCREEN, WIPE WITH A SOFT CLOTH OR USE A GERMICIDE WIPE SUCH AS SUPER SANI-CLOTH®. DO NOT SPRAY HARSH CLEANERS DIRECTLY ON THE DISPLAY TOUCH SCREEN. SEE SECTION 14 FOR COMPLETE CARE AND MAINTENANCE OF THE BD SENSICA¿ URINE OUTPUT SYSTEM. THE DEVICE WAS NOT RETURNED.