BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU30 DEVICE

    MDR report key: 6010785 · Received October 7, 2016

    Report

    Report Number
    8010762-2016-00615
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 12, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K130300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACTORY WOULD LIKE TO PROVIDE NOTIFICATION THAT THE INITIAL MEDWATCH FOR - MFG # 8010762-2016-00615 SUBMITTED OCT 7, 2016 IS A DUPLICATE SUBMISSION FOR PREVIOUSLY SUBMITTED MEDWATCH REPORT # 8010762-2016-00608 SUBMITTED OCT 5, 2016. ALL FURTHER CORRESPONDENCE REGARDING REF # (B)(4) WILL BE CONDUCTED UNDER MEDWATCH # 8010762-2016-00608.

    Additional Manufacturer Narrative · 1

    (B)(4). A MAQUET FIELD SERVICE TECHNICIAN WAS ON SITE AND INVESTIGATED THE UNIT. THE TECHNICIAN TROUBLESHOT THE DEVICE AND CHECKED THE FLOW VALUES SUCH AS THE TEMPERATURE REGULATION. THE TECHNICIAN WAS NOT ABLE TO DUPLICATE THE ERROR. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(4). THE FACTORY WOULD LIKE TO PROVIDE NOTIFICATION THAT THE INITIAL MEDWATCH - MFG # 8010762-2016-00615 SUBMITTED OCT 7, 2016 IS A DUPLICATE SUBMISSION FOR PREVIOUSLY SUBMITTED MEDWATCH REPORT # 8010762-2016-00608 SUBMITTED OCT 5, 2016. ALL FURTHER CORRESPONDENCE REGARDING REF # (B)(4) WILL BE CONDUCTED UNDER MEDWATCH # 8010762-2016-00608.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE HCU40 DISPLAYED THE ERROR MESSAGE "PAT. WATER FLOW LOW". ADDITIONAL INFORMATION: THERE WERE NO PATIENT INVOLVED THE INCIDENT OCCURRED ON START UP OF THE DEVICE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664139 MAQUET HCU30 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY AG 701044054

    Patients

    Seq Age Sex Outcome Treatment
    1