BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEOLAR VENTILATOR

    MDR report key: 18236 · Received December 6, 1994

    Report

    Report Number
    MW1004335
    Event Type
    Injury
    Date Received
    December 6, 1994
    Date of Event
    September 27, 1994
    Report Date
    October 28, 1994
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CBK
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROBLEM: NO "POWER OFF" ALARM SOUNDED ON VENTILATOR. DURING SPINE FILMS-VENT ON/OFF BUTTON ACCIDENTALLY BUMPED BY FILM CASSETTE, TURNING VENT OFF, NO ALARM SOUNDED. STAFF NOTICED SITUATION IMMEDIATELY. PT BAGGED SO NO INJURY OCCURRED. HOWEVER, THIS HAD A POTENTIAL TO CAUSE AN ADVERSE EVENT. NEEDED A GUARD TO PREVENT ACCIDENTAL SHUTOFF OF SWITCH AND BACKUP ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEOLAR VENTILATOR VENTILATOR CBK HAMILTON MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention