BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON - G5

    MDR report key: 5427425 · Received February 5, 2016

    Report

    Report Number
    2937708-2016-00001
    Event Type
    Injury
    Date Received
    February 5, 2016
    Date of Event
    January 1, 2016
    Report Date
    February 4, 2016
    Manufacturer
    HAMILTON MEDICAL, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT ON (B)(6) 2016 @ 20:24:04 THE FOLLOWING PATIENT INCIDENT OCCURRED: AS PER THE RESPIRATORY THERAPIST, THE VENTILATOR WAS IN P-SIMV MODE WITH A SET RATE OF 30 AND NOTICED THE VENTILATOR WAS DELIVERING A RATE OF 80. THE VENTILATOR WAS REMOVED FROM SERVICE. AN INTERNAL REPORT WAS FILED WITH THE FACILITIES RISK MANAGEMENT DEPARTMENT. THE LOGS ARE ATTACHED ALONG WITH A SCREENSHOT OF WHEN THE INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71254 HAMILTON - G5 G5 CBK HAMILTON MEDICAL, INC HAMILTON-G5

    Patients

    Seq Age Sex Outcome Treatment
    1