BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 10194624 · Received June 25, 2020

    Report

    Report Number
    1018233-2020-04071
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Report Date
    October 7, 2020
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    EXS
    UDI-DI
    00854003008002
    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 · 0

    THE REPORTED EVENT WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO ISOLATED TO A USE-RELATED. THE PINS ON THE LOAD CELL WERE BENT/TWISTED. (EVIDENCE OF A RING BEING TURNED TOO MUCH OR IN THE WRONG DIRECTION). THE LOAD CELL ASSEMBLY WAS REPLACED. THE SERVICING WAS PERFORMED AS PER THE TEST PROCEDURE. THE DEVICE FUNCTIONATING PROPERLY AND WAS READY FOR USE. THE PRODUCT WOULD 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 WHEN CONNECTING THE SINGLE PATIENT USE, SENSICA UO RING TO THE SYSTEM STAND, USE A FIRM, CLOCKWISE TWISTING MOTION. DO NOT APPLY EXCESSIVE FORCE OR TORQUE TO THE RING OR THE SYSTEM'S RING INTERFACE WHEN CONNECTING THE DEVICE TO AVOID DAMAGING COMPONENTS." CORRECTIONS: D10, H3. 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 HAD DAMAGED PINS. THE BIOMED PEOPLE STATED THEY WILL SEND THE DEVICE IN FOR A QUALITY CHECK.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SENSICA DEVICE HAD DAMAGED PINS. BIOMED STATED THEY WILL SEND THE DEVICE IN FOR QUALITY CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657662 SENSICA UO MONITOR ICU SENSICA MONITOR EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 SCCS-1001 NA 00854003008002

    Patients

    Seq Age Sex Outcome Treatment
    1