BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 9384600 · Received November 27, 2019

    Report

    Report Number
    1051786-2019-00055
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Report Date
    November 15, 2019
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    UDI-DI
    00884838084926
    PMA / PMN Number
    K101571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 A SWEEP SPEED ISSUE IN ROOM 1 WHERE HOST STATION (B)(4) AND FLEX CARDIO FC2010 REV-C (B)(4) WERE IN USE. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182543 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION FC2010 N/A 00884838084926

    Patients

    Seq Age Sex Outcome Treatment
    1