BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC - IFVB

    MDR report key: 3173561 · Received June 5, 2013

    Report

    Report Number
    9610825-2013-00157
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B BRAUN MEDICAL INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF B BRAUN (B)(4) (THE MFR) AND (B)(4) (THE IMP). (B)(4). THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN RETURNED FOR EVAL AND THE INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249794 VISTA BASIC - IFVB INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1