BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 11856471 · Received May 20, 2021

    Report

    Report Number
    1018233-2021-02923
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 22, 2021
    Report Date
    November 18, 2021
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    EXS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    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 SYSTEM WAS POWERED ON AND OPERATED AS NORMAL. A PHOTO SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE MET SPECIFICATION AND IT IS UNKNOWN IF WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE. THE DEVICE WAS NOT BEING USED FOR TREATMENT AT THE TIME OF THE REPORTED EVENT. THE DHR REVIEW NOT REQUIRED AS THE REPORTED ISSUE WAS UNCONFIRMED. THE LABELING REVIEW IS NOT REQUIRED AS THE REPORTED ISSUE WAS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY BD PERSONNEL THAT THE TEMPERATURE VALUE ON THE DATA SCREEN OF SENSICA DEVICE WAS DISPLAYING ERRONEOUS VALUES WHEN THE TEMPERATURE MODULE WAS NOT CONNECTED.

    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 BY BD PERSONNEL THAT THE TEMPERATURE VALUE ON THE DATA SCREEN OF SENSICA DEVICE WAS DISPLAYING ERRONEOUS VALUES WHEN THE TEMPERATURE MODULE WAS NOT CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754870 SENSICA UO MONITOR ICU SENSICA DEVICE EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other