BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 12790531 · Received November 10, 2021

    Report

    Report Number
    9610825-2021-00473
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Report Date
    February 28, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964708626
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. WHILE THE PRODUCT EVALUATION DETERMINED THAT THE REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE IDENTIFIED WHETHER THE NEED FOR COMPONENT REPAIR/REPLACEMENT ORIGINATED FROM AN ISSUE IN THE MANUFACTURING PROCESS OR DUE TO HANDLING AT THE USER FACILITY. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: BURNT LCD SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689679 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713052U 04046964708626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown