BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT P

    MDR report key: 4071941 · Received August 27, 2014

    Report

    Report Number
    9610825-2014-00329
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    August 4, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K023189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNDER INVESTIGATION AT OUR LAB IN (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTER BY THE USER FACILITY (TRANSLATION OF USER FACILITY): NO ACOUSTICAL ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519037 INFUSOMAT P INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK