BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 3773593 · Received April 3, 2014

    Report

    Report Number
    8010762-2014-00177
    Event Type
    Injury
    Date Received
    April 3, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K991864
    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 MAQUET FIELD SERVICE TECHNICIAN INVESTIGATED THE DEVICE AND REPLACED THE BATTERIES. COMPLETE FUNCTIONAL TESTING WAS SUCCESSFULLY PERFORMED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # (B)(4).

    Description of Event or Problem · 1

    REF# IMP (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203123 MAQUET CARDIOPULMONARY AG ROTAFLOW CONSOLE KFM MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1