BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLS MODULE

    MDR report key: 3480480 · Received November 8, 2013

    Report

    Report Number
    8010762-2013-00080
    Event Type
    Death
    Date Received
    November 8, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K102627
    Removal / Correction Number
    NA
    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. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). THIS EVENT IS RELATED TO MEDWATCH REPORT NUMBERS: 8010762-2013-00079, 3008355164-2013-00284.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579076 HLS MODULE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1