BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU30 DEVICE

    MDR report key: 5999851 · Received October 5, 2016

    Report

    Report Number
    8010762-2016-00607
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A MAQUET FIELD SERVICE TECHNICIAN WAS ON SITE AND INVESTIGATED THE UNIT. THE TECHNICIAN WAS NOT ABLE TO REPRODUCE THE COMPLAINT. NO PROBLEM WAS FOUND. THE TECHNICIAN RAN THE UNIT FOR THREE HOURS WITH NO PROBLEMS. THE UNIT WAS CALIBRATED, TESTED FOR FUNCTIONALITY AND SAFETY TO FACTORY SPECIFICATIONS. THE UNIT WAS SET OVERNIGHT AND CHECKED FOR PROPER OPERATION. UNIT MADE A GOOD ICE BLOCK AND WORKED FLAWLESSLY. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE HCU30 HAD AN ERROR AND STOPPED PUMPING." ADDITIONAL INFORMATION: THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT, THE DEVICE WAS EXCHANGED. REF.: #121763 CUSTOMER REF.: CP-CPL-2016-000572

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651992 MAQUET HCU30 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY AG 701034371

    Patients

    Seq Age Sex Outcome Treatment
    1