BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 10767541 · Received October 31, 2020

    Report

    Report Number
    1018233-2020-20593
    Event Type
    Malfunction
    Date Received
    October 31, 2020
    Date of Event
    October 7, 2020
    Report Date
    April 15, 2021
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    EXS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE USER RELATED ISSUE. THE DEVICE WAS OUT OF POWER AND RUNNING ON BATTERY AND THE USER DIDN'T CHARGE THE DEVICE BEFORE EACH USE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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: "IFU FOR PROPERLY CHARGING THE DEVICE: WHEN FIRST USING THE SENSICA UO SYSTEM, THE INTERNAL BACK-UP BATTERY MAY REQUIRE CHARGING. PLUG THE SYSTEM INTO A MEDICAL GRADE WALL SUPPLY USING THE POWER CORD PROVIDED, AND ALLOW A 20 HOURS TO CHARGE BATTERY. TO AVOID BATTERY DRAINAGE OVER TIME, IS RECOMMENDED TO KEEP THE SYSTEM PLUGGED INTO THE WALL DURING USE WHENEVER POSSIBLE. THE BATTERY WILL RECHARGE WHEN THE SYSTEM IS PLUGGED INTO A WALL SUPPLY. CAUTIONS: DURING SYSTEM START UP AND IN GENERAL PRACTICE, PLUG THE SENSICA UO SYSTEM INTO A WALL POWER SUPPLY WHENEVER POSSIBLE. AFTER USING THE SYSTEM ON BATTER BACK-UP, PLUG IT BACK INTO THE WALL POWER SUPPLY RECHARGING AND TO AVOID SYSTEM SHUT DOWN DUE TO A DRAINED BATTERY." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD 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 BARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SENSICA UNIT WAS NOT CALIBRATING WHICH WAS TAGGED AND GIVEN TO BIOMED AS "NOT WORKING". STATED THAT AFTER CHARGING EACH OF THE SYSTEMS, NURSE WAS ABLE TO BOOT THEM WITH NO ERRORS AND CONFIRMED THEY WERE WORKING PROPERLY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSICA UNIT WAS NOT CALIBRATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232305 SENSICA UO MONITOR ICU SENSICA MONITOR EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other