BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 11693139 · Received April 20, 2021

    Report

    Report Number
    1051786-2020-00063
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Report Date
    June 19, 2018
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF PREVIOUSLY CLOSED SERVICE ORDERS THAT WERE RECLASSIFIED AS COMPLAINTS; DISCOVERED AS PART OF A RETROSPECTIVE REMEDIATION REVIEW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PHYSICAL DAMAGE ON DCU DUE TO A FALL. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589451 INVIVO CORPORATION PATIENT MONITOR MWI INVIVO CORPORATION 453564181201

    Patients

    Seq Age Sex Outcome Treatment
    1