BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMINGBIRD

    MDR report key: 13366733 · Received January 26, 2022

    Report

    Report Number
    MW5107007
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    January 17, 2022
    Report Date
    January 24, 2022
    Manufacturer
    IRRAS USA, INC.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE HUMMINGBIRD DISPOSABLE WILL NOT KEEP A PRIME. IT KEEPS REPRIMING MORE FREQUENTLY THAT Q1H. THE CONTROL MODULE WAS REPLACED MULTIPLE TIMES AND IT WAS DETERMINED IT WAS NOT THE CONTROL UNIT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811292 HUMMINGBIRD DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM IRRAS USA, INC. A/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female