BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU30 DEVICE

    MDR report key: 4122012 · Received September 19, 2014

    Report

    Report Number
    8010762-2014-00739
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET FIELD SVC TECH INVESTIGATED THE DEVICE. A FAULTY ACTUATOR WAS FOUND AND REPLACED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCU30 DEVICE TOOK A LONG TIME TO REWARM. ERROR 1004 OCCURRED. NO PT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583651 MAQUET HCU30 DEVICE HCU30 200V-240V DWC MAQUET CARDIOPULMONARY AG 70102.4642 NA

    Patients

    Seq Age Sex Outcome Treatment
    1