BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5415280 · Received February 6, 2016

    Report

    Report Number
    2021710-2016-02909
    Event Type
    Malfunction
    Date Received
    February 6, 2016
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 UNIT WAS RETURNED TO CAREFUSION FOR EVALUATION AND REPAIR. FOUND A FAULTY POWER CORD PN 770129-102 AS THE ROOT CAUSE OF THE ISSUE. REPLACED THE POWER CORD PERFORMED A PM AND RETURNED THE UNIT TO THE CUSTOMER.

    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 THIS UNIT IS FAILING THE ELECTRICAL SAFETY TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72926 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1