BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM INFANT VENTILATOR

    MDR report key: 2801578 · Received October 18, 2012

    Report

    Report Number
    2020676-2012-00043
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 18, 2012
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR AND NOTIFIER ADDRESS: (B)(6).

    Description of Event or Problem · 1

    DURING A PRE-CLINICAL CHECK, AFTER THE VENTILATOR WAS TURNED ON, THE SCREEN WOULD NOT DISPLAY ANY OF THE PARAMETERS. THERE WERE NO VISUAL OR AUDIBLE ALARMS. THE VENTILATOR WAS TAKEN OUT OF SERVICE. THE DISTRIBUTOR REPLACED THE INTERFACE BOARD AND THE ISSUE WAS RESOLVED. THE INTERFACE BOARD IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW-UP SUBMISSION WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM INFANT VENTILATOR MILLENNIUM VENTILATOR CBK SECHRIST INDUSTRIES, INC. 23065-1

    Patients

    Seq Age Sex Outcome Treatment
    1