BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU30 DEVICE

    MDR report key: 4801832 · Received May 26, 2015

    Report

    Report Number
    8010762-2015-00673
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE (B)(4). A MAQUET FIELD SERVICE TECH INVESTIGATED THE UNIT AND PERFORMED THE FOLLOWING WORK. COMPLETE PM WITH FULL CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECS. FOUND SETPOINT POTENTIOMETER WOULD NOT OPERATE IN A LINEAR FASHION THEREFORE, MAKING IT DIFFICULT TO DIAL IN DESIRED TEMPERATURE. THE TECH REPLACED THE DEFECTIVE POTENTIOMETER. THE UNIT WAS TESTED TO FACTORY SPECS. ALL TESTS WERE PERFORMED SUCCESSFULLY.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER. "DURING PM FOUND SETPOINT POTENTIOMETER WOULD NOT OPERATE IN A LINEAR FASHION MAKING IT DIFFICULT TO OBTAIN DESIRED SETPOINT". (B)(4). (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340970 MAQUET HCU30 DEVICE DWC MAQUET CARDIOPULMONARY AG 70103.4371

    Patients

    Seq Age Sex Outcome Treatment
    1 Other