BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 10095855 · Received May 28, 2020

    Report

    Report Number
    1018233-2020-03473
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Report Date
    October 30, 2020
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    EXS
    UDI-DI
    00854003008002
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 WORKING PROPERLY. THE DEVICE WENT THROUGH FIELD ACTION, THE FOLLOWING COMPONENTS WERE REPLACED/ADDED PER THE LATEST REVISION OF THE BILL OF MATERIAL FOR SENSICA ICU,REV H BASE PCBA, REV C SENSICA ICU BASE PCBA FIRMWARE, REV D SENSICA ICU APPLICATION SOFTWARE, REV A WINDOWS ENTERPRISE OS, REV A POWER SUPPLY LABEL. PRODUCT LABEL, USB CONNECTION LABEL, WAS REPLACED WITH THE LATEST REVISION OF THE LABEL (REV C) PER THE LATEST BILL OF MATERIAL FOR SENSICA ICU. REPLACED PCBA, REV H WITH FIRMWARE. SERVICING OF THE UNIT WAS PERFORMED PER TEST PROCEDURE. THE DEVICE FUNCTIONED PROPERLY AND READY FOR USE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "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. INDICATIONS: THE SENSICA UO SYSTEM IS AN AUTOMATED URINE METER SYSTEM FOR CONTINUOUS MONITORING OF URINE OUTPUT (UO) AND CORE BODY/BLADDER TEMPERATURE (BT). TO ATTACH THE RING TO THE SENSICA UO SYSTEM STAND, TURN THE RING UPSIDE DOWN AND USE A CLOCKWISE MOTION TO TWIST AND "LOCK" THE RING ONTO THE RING INTERFACE. DO NOT APPLY EXCESSIVE FORCE OR TORQUE TO THE RING OR THE SYSTEM'S RING INTERFACE WHEN CONNECTING THE DEVICE TO AVOID DAMAGING COMPONENTS. DO NOT TURN THE RING COUNTERCLOCKWISE WHEN ATTACHING IT. " H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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 · 0

    IT WAS REPORTED THAT THE SENSICA DEVICE HAD A LOAD CELL ISSUE. PER FOLLOW UP ON 28MAY2020, ENGINEER (B)(6) STATED THE SENSICA UNIT IS BEING RETURNED TO BD FOR REPAIRS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSICA DEVICE HAD A LOAD CELL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558514 SENSICA UO MONITOR ICU SENSICA EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 SCCS-1001 NA 00854003008002

    Patients

    Seq Age Sex Outcome Treatment
    1