BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW ENGLISH/US ICU

    MDR report key: 3719961 · Received March 14, 2014

    Report

    Report Number
    8010762-2014-00141
    Event Type
    Injury
    Date Received
    March 14, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152802 ROTAFLOW ENGLISH/US ICU ROTOFLOW PUMP DWC MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1