BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MWI

    MDR report key: 10580088 · Received September 24, 2020

    Report

    Report Number
    1051786-2020-00046
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Report Date
    August 26, 2020
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    UDI-DI
    00884838039131
    PMA / PMN Number
    K152330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS FOUND TO BE PHYSICALLY DAMAGED BEYOND REPAIR. BECAUSE OF THIS, A DEFECTIVE STICKER WAS PLACED ON THE DEVICE AND THE DEVICE WAS RETURNED TO THE CUSTOMER UNREPAIRED. 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 REAR CASTER WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049128 MWI PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 866185 00884838039131

    Patients

    Seq Age Sex Outcome Treatment
    1