SENSICA URINE OUTPUT SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE DID NOT POWER ON. IN EVALUATION FINDINGS IT HAS BEEN NOTED THAT THE DEVICE WAS RECEIVED IN WITH CRITICAL DAMAGE TO LOAD CELL PINS.

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.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CAPTURE THE INVESTIGATION DETAILS. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO HEALTH CONSEQUENCES NOR IMPACT REPORTED BY USER. THUS, THIS EVENT IS NOT REPORTABLE. THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE DEVICE WAS EVALUATED UPON RECEIPT. UNABLE TO REPLICATE THE DEVICE STARTUP ISSUE IN THE SERVICE DEPOT. THE DEVICE HAS SUCCESSFULLY PASSED MULTIPLE BATTERY CHARGE AND DISCHARGE CYCLES WITH OPTIMAL BATTERY READINGS. THE DEVICE ALSO HAS THE ABILITY TO POWER ON AND OFF WITH AND WITHOUT THE POWER CORD BEING PLUGGED INTO THE DEVICE. CONNECTIONS THROUGHOUT THE SYSTEM ARE FREE OF DAMAGE. THE DEVICE WAS NOT SENT IN WITH THE POWER CABLE THAT COMES WITH DEVICE, SO UNABLE TO IDENTIFY IF THE PROBLEM COULD BE THE POWER CORD BEING USED IN THE FIELD. SENT CUSTOMER NEW POWER CORD ASSEMBLY. DEVICE WAS RECEIVED IN WITH CRITICAL DAMAGE TO LOAD CELL PINS AND THE FRONT PLATE REMOVED FROM THE LOAD CELL. REPLACED DEVICES LOAD CELL ASSEMBLY. THE REPORTED EVENT IS UNCONFIRMED, RISK REVIEW, LABELING/PACKAGING REVIEW, AND DHR REVIEW ARE NOT REQUIRED. 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 DID NOT POWER ON. IN EVALUATION FINDINGS IT HAS BEEN NOTED THAT THE DEVICE WAS RECEIVED IN WITH CRITICAL DAMAGE TO LOAD CELL PINS.