SENSICA URINE OUTPUT SYSTEM
Received Aug 21, 2024 · Event occurred Jul 29, 2024
Report 1018233-2024-05028 · MDR key 20013225
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Computer Operating System Problem
- Computer Operating System Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 WOULD BE SENT TO THE DEPOT FOR ASSESSMENT OF OPERATING SYSTEM. DEVICE WOULD NOT ALLOW FOR THE OS RE-IMAGE DURING SOFTWARE UPDATE, STOPPED AT 45 PERCENTAGE AND GAVE AN ERROR.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA DEVICE WOULD BE SENT TO THE DEPOT FOR ASSESSMENT OF OPERATING SYSTEM. DEVICE WOULD NOT ALLOW FOR THE OS RE-IMAGE DURING SOFTWARE UPDATE, STOPPED AT 45 PERCENTAGE AND GAVE AN ERROR.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CAPTURE THE INVESTIGATION DETAILS. THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE RISK DOCUMENT WAS PERFORMED FOR THE INVESTIGATION. THE REPORTED EVENT IS ADDRESSED, AND THE RESIDUAL RISK FOR THIS EVENT IS LOW; THEREFORE, THIS EVENT IS NOT REPORTABLE. THE DEVICE WAS NOT RETURNED. THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. THE INSTRUCTIONS-FOR-USE ARE FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.