BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMINGBIRD

    MDR report key: 7295809 · Received February 23, 2018

    Report

    Report Number
    MW5075487
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Date of Event
    February 7, 2018
    Report Date
    February 9, 2018
    Manufacturer
    INNERSPACE
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CATHETER WITHIN THE HUMMINGBIRD DEVICE WAS NO LONGER IN PATENT POSITION, REQUIRING DEVICE REMOVAL. DEVICES WILL BE RETURNED ONLY IF MANUFACTURERS PROVIDE PREPAID SHIPPING, PACKAGING AS PER DOT, OR PICK THE ITEM UP. THE DETAILS IN THIS REPORT IS THE EXTENT TO WHICH WE IDENTIFY MEDICATIONS INVOLVED OR PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137344 HUMMINGBIRD DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM INNERSPACE HVMV600MR HVMV600MR

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR