BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEL

    MDR report key: 2974593 · Received January 17, 2013

    Report

    Report Number
    2031702-2013-00009
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    January 17, 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
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR STOPPED VENTILATING WITH AN AUDIBLE ALARM WHILE CONNECTED TO A PT. IT WAS ALSO REPORTED THAT THERE WAS NO ALARM AT THE NURSE CALL STATION. NO PT HARM REPORTED. THE VENTILATOR WAS CHECKED BY THE USER FACILITY STAFF AND THEY FOUND NO PROBLEMS WITH THE VENTILATOR. THE VENTILATOR WAS PLACED ON ANOTHER PT. THE VENTILATOR SHUT DOWN WITH AUDIBLE ALARM WHILE CONNECTED TO THE SECOND PT. NO PT HARM REPORTED. THERE WAS AN AUDIBLE ALARM AT THE NURSE CALL STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27294 REVEL VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC 19260-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI