BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 3897006 · Received June 6, 2014

    Report

    Report Number
    9610825-2014-00226
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    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). A REQUEST HAS BEEN MADE TO RETURN THE DEVICE FOR EXAMINATION TO OUR BBM SERVICE LABORATORY IN (B)(4). AT THIS TIME, THE DEVICE HAS NOT BEEN RECEIVED YET. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333169 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1