BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 11692117 · Received April 20, 2021

    Report

    Report Number
    1051786-2021-00005
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Report Date
    December 30, 2018
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K101571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF PREVIOUSLY CLOSED SERVICE ORDERS THAT WERE RECLASSIFIED AS COMPLAINTS; DISCOVERED AS PART OF A RETROSPECTIVE REMEDIATION REVIEW. 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 ISSUE WITH THE AMPLIFIER WITH THE FLEX CARDIO. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589504 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM PHYSIOMONITORING SYSTEM MANAGEMENT DEVICE MWI INVIVO CORPORATION 453564243591

    Patients

    Seq Age Sex Outcome Treatment
    1