BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA

    MDR report key: 9538907 · Received January 2, 2020

    Report

    Report Number
    1018233-2020-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Report Date
    February 21, 2020
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    EXS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED DUE TO THE INABILITY TO REPRODUCE THE ISSUE. THE TECH COULD NOT DUPLICATE THE REPORTED ISSUE DURING TESTING. UNIT WAS FUNCTIONALLY TESTED AND NO ISSUES WERE SIGHTED. 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 MONITOR DISPLAY SHOWS HOW FULL THE BAG IS, UPDATING CONTINUOUSLY ALONG WITH THE CURRENT HOUR UO MEASUREMENT." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT ACCURATELY RECORDING VOLUME. THE COMPLAINANT NOTED THE DEVICE WAS 50-100CC OFF OF THE ACCURATE READING EVERY HOUR.

    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 THAT THE SENSICA DEVICE WAS NOT ACCURATELY RECORDING VOLUME. THE COMPLAINANT NOTED THE DEVICE WAS 50-100 CC OFF OF THE ACCURATE READING EVERY HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4732 SENSICA SENSICA EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1