BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 3953213 · Received June 20, 2014

    Report

    Report Number
    3008355164-2014-00117
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD DISPLAY A RUN-AWAY ERROR ON THE SCREEN WHILE BEING USED ON A PT. THE DEVICE WAS EXCHANGED FOR ANOTHER. NO REPORTED PT EFFECT. (B)(4). REF MFR REPORT#: 8010762-2014-00244.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363204 MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE KFM MAQUET CARDIOPULMONARY AG MCP0.0702697

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R