BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 3952236 · Received June 30, 2014

    Report

    Report Number
    9610825-2014-00245
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN INVESTIGATED BY OUR TECHNICIAN ACCORDING TO THE TECHNICAL SAFETY CHECK. RESULT: NO FAILURE WAS DETECTED. THE DEVICE OPERATED AS INTENDED. NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT. A FOLLOW-UP REPORT WILL NOT BE PROVIDED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379154 INFUSOMAT SPACE VOLUMETRIC PUMP FPA B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1