BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

    MDR report key: 9241552 · Received October 25, 2019

    Report

    Report Number
    1218950-2019-08171
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    October 22, 2019
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    UDI-DI
    00884838082113
    PMA / PMN Number
    K101571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILED TO WORK AS EXPECTED BY THE CUSTOMER. TO RESOLVE THE ISSUE, THE FLEX CARDIO DEVICE WAS REPLACED. THE ABSENCE OF FURTHER CALLS SUPPORTS THAT THE REPORTED PROBLEM HAS NOT RECURRED AND WAS RESOLVED. A REPLACEMENT DEVICE IS NOW IN USE AT THE CUSTOMER'S FACILITY. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED BASED ON THE AVAILABLE INFORMATION AT THE TIME OF COMPLAINT CLOSURE.

    Additional Manufacturer Narrative · 1

    REFERENCE MANUFACTURERS REPORT 1051786-2020-00004 SUBMITTED FOR CORRECTION OF REGISTRATION NUMBER.

    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 THE SWEEP SPEED IS OFF AND A DELAY IN IMAGE #2. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037319 XPER FLEX CARDIO PHYSIOMONITORING SYSTEM PHYSIOMONITORING SYSTEM MANAGEMENT DEVICE MWI INVIVO CORPORATION 453564243591 N/A 00884838082113

    Patients

    Seq Age Sex Outcome Treatment
    1