BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 11615877 · Received April 5, 2021

    Report

    Report Number
    1018233-2021-80029
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Report Date
    April 5, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO A FAULTY PRINTED CIRCUIT BOARD THAT INTERMITTENTLY STOPS PROVIDING THE ADEQUATE POWER (5 VOLTS) TO RUN THE USB CONNECTIONS. THE PRINTED CIRCUIT BOARD WOULD NOT PROVIDE A CONSTANT 5 VOLTS TO THE USB PORT. THE PRINTED CIRCUIT BOARD WAS FOUND TO HAVE AN INTERMITTENT POWER ISSUE WHEN TRYING TO PROVIDE 5 VOLTS FOR USB PORT. THE PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED. THE LOAD CELL PIN WAS BENT AND DAMAGED CAUSING THE SYSTEM NOT TO THE DETECT RING DURING THE NEW SESSION SETUP. THE LOAD CELL ASSEMBLY WAS REPLACED. THE SERVICE WAS PERFORMED ON THE DEVICE AS PER THE TEST PROCEDURE. THE DEVICE WAS FUNCTIONING PROPERLY AND READY FOR USE. IT WAS UNKNOWN WHETHER THE UNIT WAS BEING USED FOR THE TREATMENT AT THE TIME OF THE REPORTED EVENT. THE PRODUCT DID NOT MEET THE SPECIFICATIONS, AND WAS INFLUENCED BY THE REPORTED FAILURE. 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. THE SENSICA UO SYSTEM FOR ICU IS DESIGNED FOR PRECISE MEASUREMENT USING THE DISPOSABLE, SENSICA UO RING, WHICH IS PART OF THE SENSICA UO PATIENT RING KIT. EACH TIME THE SYSTEM IS USED WITH A NEW PATIENT, A NEW SENSICA UO RING MUST BE CONNECTED TO THE SENICA UO STAND. THE SYSTEM SOFTWARE IS DESIGNED TO CALIBRATE EACH TIME A NEW RING IS ATTACHED TO ENSURE ACCURATE CALCULATIONS OF URINE OUTPUT VOLUME."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512718 SENSICA UO MONITOR ICU SENSICA UO MONITORICU EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1