BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VKMO 31000-USA-QUADROX-I

    MDR report key: 3812031 · Received April 25, 2014

    Report

    Report Number
    8010762-2014-00191
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    February 10, 2014
    Report Date
    March 26, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252091 VKMO 31000-USA-QUADROX-I QUADROX OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG VKMO 31000 70077962

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other