BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5418351 · Received February 8, 2016

    Report

    Report Number
    2021710-2016-03025
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 CUSTOMER WAS SENT A PRESSURE TRANSDUCER PN 122-8006 AND A COILED TUBING PN770115. AS OF THIS DATE THE PARTS HAVE NOT BEEN RECEIVED FOR EVALUATION. WHEN THEY HAVE 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 TO REPORT THAT CONDENSATION GOT UP INTO THE PRESSURE XDCR AND COILED TUBING. THEY WERE CHECKING OUT THE VENT AND NOTICED MURKY WATER INSIDE THE COILED TUBING. THERE WAS NO INDICATION OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74973 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1