BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 2922650 · Received December 27, 2012

    Report

    Report Number
    2031702-2012-00324
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN WITH AN AUDIBLE ALARM. IT WAS BEING SET-UP FOR A PATIENT WHEN THE REPORTED PROBLEM OCCURRED. NO PATIENT HARM REPORTED. THE VENTILATOR AND BATTERY HAD BEEN OUTSIDE IN THE NIGHT WITH TEMPERATURES OF 35-40 DEGREES WHEN THE REPORTED PROBLEM OCCURRED. AFTER THE VENTILATOR AND BATTERY WERE WARMED UP, IT POWERED ON WITHOUT FAULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI