BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 19699072 · Received July 9, 2024

    Report

    Report Number
    8010762-2024-00347
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 15, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE, THAT THIS COMPLAINT# 1072061 (MFG REPORT NUMBER: 8010762-2024-00347) IS A DOUBLE ENTRY TO THE ALREADY REPORTED COMPLAINT# (B)(4) (MFG REPORT NUMBER: 8010762-2024-00328). THIS WAS CONFIRMED BY THE SERVICE AND SALES UNIT. THEREFORE THIS COMPLAINT WILL NOT FURTHER INVESTIGATED AND CLOSED. ALL FURTHER INVESTIGATION STEPS WILL BE DONE WITHIN THE ALREADY OPENED AND REPORTED COMPLAINT# (B)(4) (MFG REPORT NUMBER: 8010762-2024-00328).

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED: ¿BACK FLOW ERROR WHEN ON PAT¿ AND ¿BACK FLOW ERROR, NOT CLEARING FOR STAFF¿ THE EVENT OCCURRED DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210477 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown