BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3233024 · Received July 10, 2013

    Report

    Report Number
    9610825-2013-00202
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    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) (MANUFACTURER), AND (B)(4) (IMPORTER). (B)(4). THE ACTUAL DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS ON GOING AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314807 INFUSOMAT SPACE - US VERSION INFUSION PUMP FPA B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1