BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5416284 · Received February 8, 2016

    Report

    Report Number
    2021710-2016-02997
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 WENT ONSITE AND FOUND THAT THERE WAS LOT OF HUMIDITY IN THE CIRCUIT AND THE PRESSURE SENSE LINE. THE FSE REPLACED THE PRESSURE XDCR AND THE INTERNAL TUBING TO THE TRANSDUCER. PERFORMED OVP AND UVT. VENT WORKING AS PER SPECIFICATIONS. AS OF THIS DATE THE PART HAS NOT BEEN RECEIVED FOR EVALUATION. WHEN IT HAS BEEN RECEIVED AND EVALUATED A SUPPLEMENT WILL BE FILED.

    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 AND REPORTED THAT THE UNIT FAILED ON A PATIENT. THE DRIVER STOPPED TWICE WITHOUT ANY CAUSE. THE PATIENT WAS PLACED ON A DIFFERENT VENT AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76398 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1