BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-ID AD.O.FIL

    MDR report key: 4606202 · Received March 12, 2015

    Report

    Report Number
    3008355164-2015-00040
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 13, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SECOND DEVICE LEAKED SEVERELY FROM THE GAS OUTLET PRIOR TO INITIATION OF USE. THIS EVENT IS RELATED TO MEDWATCH REPORT # 8010762-2015-00251 AND 3008355164-2015-00039 FOR THE FIRST DEVICE. (B)(4). REFERENCE 8010762-2015-00252.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171157 QUADROX-ID AD.O.FIL BEQ-HMOD70000-USA QUADROX-ID AD.O.FIL. DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA 70100295

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other