BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT

    MDR report key: 1771336 · Received July 21, 2010

    Report

    Report Number
    1771336
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    June 2, 2010
    Report Date
    July 21, 2010
    Manufacturer
    IMPACT INSTRUMENTATION, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT REQUIRED VENTILATOR IN SPECIALS ROOM. VENTILATOR CONTINUALLY ALARMED DURING PROCEDURE, INDICATING ISSUES WITH BATTERY. MACHINE APPEARED TO BE VENTILATING PATIENT APPROPRIATELY.======================HEALTH PROFESSIONAL'S IMPRESSION======================THERE WAS NO ADVERSE EVENT PER SE. THE STAFF QUESTIONED THE FUNCTION OF THE VENTILATOR GIVEN THE CONSTANT ALARMING.======================MANUFACTURER RESPONSE FOR VENTILATOR, EAGLE 754 / 754M======================THEY COULD NOT REPRODUCE THE BATTERY ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-VENT VENTILATOR, CONTINUOUS, FACILITY USE CBK IMPACT INSTRUMENTATION, INC 754 EAGLE NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR OTHER