BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 3132348 · Received May 1, 2013

    Report

    Report Number
    2031702-2013-00101
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE VENTILATOR WAS CHECKED OUT AND WAS FUNCTIONING FINE, ONE OF THE FAMILY MEMBERS INDICATED THAT THEIR MOTHER WAS BREATHING FUNNY. WHEN THE THERAPIST WENT INTO THE PT'S ROOM, SHE FOUND THE VENTILATOR WAS OFF. THE VENTILATOR WAS TURNED ON AND WAS FUNCTIONING FINE. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190945 REVEL VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC 19260-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1