BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU30 DEVICE

    MDR report key: 5233710 · Received November 18, 2015

    Report

    Report Number
    8010762-2015-01183
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 19, 2015
    Report Date
    October 20, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOVEMBER 18, 2015 10:28 AM (GMT-5:00) ADDED BY (B)(6): (B)(4). A MAQUET FIELD SERVICE TECHNICIAN WAS ON SITE AND INVESTIGATED THE UNIT. THE TECHNICIAN CONFIRMED THE PROBLEM THAT THE ICE BLOCK IS TOO LARGE IN THE ICE MAKING STAGE. THE UNIT WAS SENT TO REPAIR DEPOT WHERE THE ICE SENSOR WAS REPLACED. FUNCTIONALITY TESTS AND A SAFETY CHECK AS PER THE SERVICE MANUAL WERE PERFORMED. ALL TESTS WERE PERFORMED SUCCESSFULLY. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE ICE MAKING STAGE THE ICE BLOCK WAS TOO LARGE AND WOULD NOT MAKE A PROPER SIZE BLOCK. SYSTEM TO BE SENT TO THE (B)(4) OFFICE FOR A ICE SENSOR REPLACEMENT. THE INCIDENT OCCURRED DURING PREVENTIVE MAINTENANCE SO THERE WERE NO PATIENT INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763181 MAQUET HCU30 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY AG 70102.8718

    Patients

    Seq Age Sex Outcome Treatment
    1