BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 11646230 · Received April 9, 2021

    Report

    Report Number
    1018233-2021-80030
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    EXS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED HOWEVER THE CAUSE WAS UNKNOWN. THE ROOT CAUSE OF THE REPORTED ISSUE COULD BE DUE TO AN ERROR, 1.1 A CRITICAL TEMPLATE FILE THAT DID NOT PROPERLY DOWNLOAD DURING INSTALLATION. IT WAS FOUND THAT DURING ORIGINAL INSTALLATION OF SW VERSION 1.1 THAT A CRITICAL TEMPLATE FILE FOR THE ELECTRONIC HEALTH RECORD (EHR) CONNECTIVITY WAS NOT PRESENT. VERSION 1.1 WAS RE-INSTALLED AND MADE SURE THAT THE PROPER TEMPLATE FILE WAS DOWNLOADED CORRECTLY. SERVICING OF THE UNIT WAS PERFORMED PER TEST PROCEDURE. THE DEVICE FUNCTIONED PROPERLY AND WAS 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 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 THERE WAS AN ELECTRONIC HEALTH RECORDS (EHR) SETTING ISSUE WITH THE SENSICA DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542984 SENSICA UO MONITOR ICU SENSICA UO MONITOR EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1