BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 11202187 · Received January 20, 2021

    Report

    Report Number
    1051786-2021-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Report Date
    January 11, 2021
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    UDI-DI
    00884838084926
    PMA / PMN Number
    K101571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10:THE DEVICE DID NOT BEHAVE AS EXPECTED BY THE CUSTOMER. TO RESOLVE THE REPORTED ISSUE, THE DEVICE WAS REBOOTED. ALTHOUGH THE REPORTED ISSUE WAS RESOLVED BY REBOOTING THE DEVICE, IT IS NOT KNOWN WHAT CAUSED THE CUSTOMER'S ISSUE INITIALLY. THEREFORE, WE ARE CONSIDERING THIS TO BE A MALFUNCTION OF UNKNOWN CAUSE. THE DEVICE REMAINS IN USE AT THE CUSTOMER'S SITE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLEX CARDIO NIBP IS NOT REFRESHING PROPERLY, AND HOLDS THE SAME NUMBERS FOR AN EXTENDED PERIOD. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102455 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION FC2010 N/A 00884838084926

    Patients

    Seq Age Sex Outcome Treatment
    1