BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP-I

    MDR report key: 6325498 · Received February 13, 2017

    Report

    Report Number
    8010762-2017-00039
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 13, 2017
    Report Date
    July 25, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT PLACE A SERVICE REQUEST TO MAQUET FOR THIS ISSUE/DEVICE. THEREFORE NO EVIDENCE OF INVESTIGATION OR REPAIR IS AVAILABLE. THE MAQUET SALES AND SERVICE UNIT CONTACT STATED HE WAS NOT AWARE OF ANY SERVICE REQUEST FOR THIS DEVICE AND BELIEVES THE DEVICE IS STILL IN USE AND THE CUSTOMER HAS NOT REPORTED ANY FURTHER PROBLEMS. AN INVESTIGATION OF THE DISPOSABLE USED IN THIS CASE TOOK PLACE BY LIFE CYCLE ENGINEERING DEPARTMENT UNDER COMPLAINT 130983, NO FAILURE WAS FOUND. THIS COMPLAINT WILL THEREFORE BE CLOSED, HOWEVER IT MAY BE RE-OPENED IF ANY NEW RELEVANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE NO. (B)(4).

    Description of Event or Problem · 1

    DURING PATIENT TREATMENT IT WAS REPORTED, THAT ON THE TRANSPORT FROM (B)(6) TO THE UNITED STATES OF AMERICA THE ERROR MESSAGE: ¿CIRCUIT DISPOSABLE ERROR¿ WAS DISPLAYED AND THEY SWITCHED TO MANUAL SUPPORT WITH THE HAND CRANK,BEFORE THEY SUCCESSFULLY TRANSFERRED TO ANOTHER CARDIOHELP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109080 CARDIOHELP-I CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG 701048012

    Patients

    Seq Age Sex Outcome Treatment
    1