BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID

    MDR report key: 2822786 · Received November 2, 2012

    Report

    Report Number
    8010762-2012-00044
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 5, 2012
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE OXYGENATOR HAS BEEN RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION IS IN-PROCESS AND A SUPPLEMENTAL MEDWATCH WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PRIMING THE OUTLET PORT BECAME DETACHED. NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX-ID OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG HMOD70000-USA 70064107

    Patients

    Seq Age Sex Outcome Treatment
    1