BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU30 DEVICE

    MDR report key: 4955974 · Received July 29, 2015

    Report

    Report Number
    8010762-2015-00852
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    April 6, 2015
    Report Date
    July 7, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN INVESTIGATED THE UNIT AND FOUND THAT THE UNIT WAS FIVE YEARS OLD AND HAD NEVER BEEN SERVICED. HE PERFORMED A FULL SERVICE AND REPLACED ALL DEFECTIVE OR WORN PARTS AS PER SERVICE ORDER (B)(4). HE COMPLETED THE SYSTEM RESTORE, COMPLETE PM, CALIBRATION, FULL FUNCTIONAL TESTS AND SAFETY TESTS AS PER THE SERVICE MANUAL. THE UNIT PASSED ALL TESTS. THIS IS THE FINAL REPORT FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN WILL INVESTIGATED THE UNIT IN QUESTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE IT WAS NOTICED THAT AFTER A SHORT TIME AFTER THE START UP OF THE SYSTEM AN ALARM APPEARS AND ERROR 1004-02 IS DISPLAYED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). THE INITIAL REPORT FOR THIS COMPLAINT WAS SUBMITTED ON PAPER JULY 30,2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494713 MAQUET HCU30 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY AG MCP00704629#

    Patients

    Seq Age Sex Outcome Treatment
    1