BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 11596260 · Received March 31, 2021

    Report

    Report Number
    1018233-2021-80028
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Report Date
    March 31, 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 ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS CAUSED BY A FAULTY PCB THAT INTERMITTENTLY STOPS PROVIDING ADEQUATE POWER (5 VOLTS) TO RUN USB CONNECTIONS. THE PCB WOULD NOT PROVIDE A CONSTANT 5 VOLTS TO THE USB PORT. THE PCB IS FOUND TO HAVE AN INTERMITTENT POWER ISSUE WHEN TRYING TO PROVIDE 5V FOR USB PORT. THE PCB ASSEMBLY WAS REPLACED. SERVICING OF THE UNIT WAS PERFORMED PER TEST PROCEDURE. THE DEVICE FUNCTIONS PROPERLY AND IS 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: "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. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSICA DEVICE HAD AN ERROR 0,6,1,0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491550 SENSICA UO MONITOR ICU SENSICA UO MONITOR ICU EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1