BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW 2-PUMPS CONSOLE

    MDR report key: 4805158 · Received May 28, 2015

    Report

    Report Number
    8010762-2015-00665
    Event Type
    Injury
    Date Received
    May 28, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE, MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE CUSTOMER ORDERED THEIR OWN POWER CORD; SINCE THEIR'S WAS FRAYED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346139 ROTAFLOW 2-PUMPS CONSOLE DTQ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1