BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 3173560 · Received June 5, 2013

    Report

    Report Number
    9610825-2013-00152
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B BRAUN MELSUNGEN AG (MFR). THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN (B)(4). THE DEVICE IS CURRENTLY BEING SENT TO (B)(4), FOR EVAL. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE EVAL RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249252 PERFUSOR SPACE VOLUMETRIC PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1