BEUDAMED
    FDA Adverse Event Summary report: N

    HKI-CIRCUITS

    MDR report key: 3836242 · Received April 30, 2014

    Report

    Report Number
    2242551-2014-00010
    Date Received
    April 30, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    CAREFUSION-GE HEALTHCARE FINLAND OY
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION ACQUIRED GE VITAL SIGNS ON (B)(4) 2013. A RETROSPECTIVE REVIEW OF ALL COMPLAINTS POST ACQUISITION WAS PERFORMED. THIS COMPLAINT WAS IDENTIFIED AS BEING MDR REPORTABLE BY (B)(4) STANDARDS AND IS BEING SUBMITTED TO THE FDA. UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WE HAVE A NEW COMPLAINT FROM (B)(6) ABOUT A LEAK OF THE HMEF750S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258294 HKI-CIRCUITS PATIENT CIRCUIT AND COMPONENTS, DISP CAI CAREFUSION-GE HEALTHCARE FINLAND OY M1135230 131693

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other