BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5414175 · Received February 5, 2016

    Report

    Report Number
    2021710-2016-02856
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    January 31, 2014
    Report Date
    January 31, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 REPLACED THE DRIVER. A FAILURE ANALYSIS WAS PERFORMED. FOUND THAT A TINSEL WIRE IS BROKEN AND DUPLICATED THAT THE DRIVER STOPPED. THIS IS A KNOWN ISSUE THAT HAS BEEN ADDRESSED VIA AN INTERNAL ACTION. FINDING/ROOT-CAUSE: DEFECTIVE TINSEL WIRE ASSEMBLY PN 23111-001.

    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 DRIVER ON THIS VENT STOPPED WHILE ON A PATIENT. THE OVERHEAT LIGHT WAS ON. THE CUSTOMER STATED THAT THE UNIT ALARMED APPROPRIATELY WHEN THE DRIVER STOPPED. THE END-USERS WERE ABLE TO ATTEND TO THE PATIENT WITHOUT ANY COMPROMISE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71134 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1