BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 11543752 · Received March 22, 2021

    Report

    Report Number
    1051786-2021-00004
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Report Date
    March 6, 2021
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K101571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE AND CONFIRMED THE REPORTED PROBLEM. THE DEVICE DID NOT BEHAVE AS EXPECTED BY THE CUSTOMER. TO RESOLVE THE ISSUE, THE FSE REPLACED THE FLEX CARDIO DEVICE. THE NEW 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SWEEP SPEED IS INCREASING AUTOMATICALLY. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445223 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM CARDIOVASCULAR MONITOR MWI INVIVO CORPORATION 453564243591 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1