BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU 30 DEVICE

    MDR report key: 4908351 · Received July 9, 2015

    Report

    Report Number
    8010762-2015-00794
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE (B)(4). A MAQUET FIELD SERVICE TECHNICIAN WILL INVESTIGATE THE UNIT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). A MAQUET FIELD SERVICE TECHNICIAN INVESTIGATED THE UNIT AND COULD NOT REPRODUCE THE REPORTED ISSUE. THE TECHNICIAN RAN THE HCU 30 FOR APPROXIMATELY 1 HOUR, HEATING AND COOLING TO TARGET TEMPERATURE, WITH NO PROBLEMS OBSERVED. ICE BLOCK APPEARED TO BE OF SUFFICIENT SIZE. BROUGHT BOTH CARDIO AND MAIN SIDE TO APPROXIMATELY 4C WITH NO PROBLEM. ALSO, PERFORMED PT1000 DIVERGENT TEST. ALL TESTS WERE PERFORMED SUCCESSFULLY. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER: "THE UNIT WILL NOT COOL DOWN. IT WOULD NOT GO LOWER THAN 18 DEGREES. THIS EVENT OCCURRED WHILE ON A PATIENT. NO PATIENT HARM OR INJURY WERE REPORTED." (B)(4). (B)(6).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446895 MAQUET HCU 30 DEVICE DWC MAQUET CARDIOPULMONARY AG 70102.8718

    Patients

    Seq Age Sex Outcome Treatment
    1