BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU ACTION PUMP

    MDR report key: 7071505 · Received November 30, 2017

    Report

    Report Number
    MW5073651
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 21, 2017
    Report Date
    November 28, 2017
    Manufacturer
    AMBU INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ABOUT 2 HRS AFTER AMBU ACTION PUMP WITH ROPIVACAINE 0.2%, 600 ML WAS HUNG, PRODUCT STARTED TO LEAK. PRODUCT REMOVED AND NEW PUMP HUNG FOR PT. NO HARM TO PT DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852377 AMBU ACTION PUMP AMBU ACTION PUMP INFUSION MEB AMBU INC. 19471807

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR