BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2821129 · Received October 29, 2012

    Report

    Report Number
    9610825-2012-00224
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 31, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B BRAUN MEDICAL INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF B BRAUN (B)(4) (THE MFR), AND (B)(4) (THE IMPORTER). (B)(4). A HISTORY REVIEW OF THE CUSTOMER COMPLAINT DATABASE WAS CONDUCTED FOR COMPLAINT TRENDS OF A SIMILAR NATURE, AND NO ADVERSE TRENDS WERE IDENTIFIED. THE MFR'S INVESTIGATION INTO THIS EVENT IS ON-GOING AT THIS TIME. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: (B)(4), POWER ARC, PLUG BURNT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other