BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER FLEX CARDIO 2010 REV D RUSSIA

    MDR report key: 9451309 · Received December 11, 2019

    Report

    Report Number
    1051786-2019-00060
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    November 21, 2019
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K101571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE INSTALLATION, A MALFUNCTION OF THE UPS FROM FLEX CARDIO (FAILED THE ELECTRICAL SAFETY TEST) AND THE MALFUNCTION OF THE UPS OF THE SYSTEM ITSELF IS NOT POSSIBLE TO ESTABLISH THE VOLTAGE OF 400 V. THE DEVICE WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250208 XPER FLEX CARDIO 2010 REV D RUSSIA XPER FLEX CARDIO PHYSIOMONITORING SYSTEM MWI INVIVO CORPORATION FC2010 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1