BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM

    MDR report key: 9249420 · Received October 29, 2019

    Report

    Report Number
    1051786-2019-00045
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Report Date
    October 23, 2019
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    UDI-DI
    00884838084919
    PMA / PMN Number
    K101571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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

    THE CUSTOMER REPORTED THAT THE FLEX CARDIO SWEEP SPEED ON THE BOOM MONITOR ABRUPTLY CHANGES TO 400+ MM/SEC. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047970 PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM PHYSIOMONITORYING SYSTEM, INFO MWI INVIVO CORPORATION FC2010 N/A 00884838084919

    Patients

    Seq Age Sex Outcome Treatment
    1