BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 8217984 · Received January 4, 2019

    Report

    Report Number
    1051786-2019-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Report Date
    January 2, 2019
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DQA
    UDI-DI
    00884838012585
    PMA / PMN Number
    K103700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE DEVICE WAS DEFECTIVE ON ARRIVAL AND THAT THE SPEAKER HAS NO FUNCTION AND THERE IS NO ALARM SIGNAL. THE DEVICE WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9317 INVIVO CORPORATION PATIENT MONITOR DQA INVIVO CORPORATION 865353 00884838012585

    Patients

    Seq Age Sex Outcome Treatment
    1