BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES FOR SPACE PUMPS

    MDR report key: 4071938 · Received August 25, 2014

    Report

    Report Number
    9610825-2014-00315
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 11, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K083689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MED INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MFR) AND B. BRAUN MED INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE ACTUAL SAMPLE INVOLVED HAS NOT BEEN RECEIVED YET FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT DESCRIPTION: CUSTOMER STATES, THERMAL DAMAGE TO CORD. PUMP WAS IN ROOM BUT NOT ON USE ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510959 ACCESSORIES FOR SPACE PUMPS US POWER CORD INCL. EXTENSION FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK