SENSICA UO SYSTEM

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

THE SENSICA URINE OUTPUT SYSTEM TOUCHSCREEN NEED UPDATE, AND FAILED THE DURING SCREEN CALIBRATION.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE IDENTIFIED IS A FAILED TABLET/PC. THE DEVICE WAS EVALUATED UPON RECEIPT. THE SENSICA TOUCHSCREEN FAILED THE DURING CALIBRATION, AND TESTING. REPLACED TABLET/PC. OTHER MAINTENANCE PERFORMED. APPLIED THE OPTICAL SENSOR GASKET FOAM, THE TAMPER EVIDENT LABELS, AND NEW GROUND WIRE. COMPLETED FINAL FUNCTIONAL. DHR IS NOT REQUIRED AS THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. THE LABELLING REVIEW SIS NOT REQUIRED AS THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

Description of Event or Problem

THE SENSICA URINE OUTPUT SYSTEM TOUCHSCREEN NEED UPDATE, AND FAILED THE DURING SCREEN CALIBRATION.