BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5426895 · Received February 10, 2016

    Report

    Report Number
    2021710-2016-03098
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT WAS IDENTIFIED AS A LATE SUBMISSION DURING A TWO YEAR RETROSPECTIVE REVIEW OF COMPLAINTS AND MDR¿S FOLLOWING RECEIPT OF AN UNTITLED LETTER ISSUED BY THE FDA. THE CAREFUSION FSE WENT ON SITE AND FOUND A BIAS FLOW OF 15, POWER 3.50, MEAN PRESSURE MONITOR AT 14.6, ALARM MAX PAW OF 22 AND ALARM MIN PAW OF 14. THE FSE CHECKED THE ALARM FUNCTIONS AND THE PATIENT CALIBRATION AND ALL WAS OK NOW. THE FSE RAN THE VENT MORE THAN ONE HOUR WITH THE SETUP ABOVE AND WAS UNABLE TO FIND ANY PROBLEMS. THE UNIT IS MEETING ALL MANUFACTURE AND SPECIFICATION.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN A RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE ON (B)(6) 2014. THE CUSTOMER CALLED TO REPORT THAT THE VENTILATOR SHUT DOWN (POWERED DOWN - NO LIGHTS) WHILE ON A PATIENT. THE VENT DID ALARM SO THEY WERE ABLE TO SWITCH OUT THE VENT WITHOUT ANY PATIENT COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85815 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1