BEUDAMED
    FDA Adverse Event Death Summary report: N

    70104.8012# CARDIOHELP-I

    MDR report key: 5318979 · Received December 22, 2015

    Report

    Report Number
    8010762-2015-01278
    Event Type
    Death
    Date Received
    December 22, 2015
    Date of Event
    November 23, 2015
    Report Date
    November 23, 2015
    Manufacturer
    MAQUET MEDICAL SYSTEMS, USA
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS INVESTIGATED BY A MAQUET FIELD SERVICE TECHNICIAN UNDER SERVICE ORDER (B)(4), WHERE A NEW TOUCH PANEL (LOT NO. 3000012877) WAS INSTALLED AND A COMPLETE PM, FULL FUNCTIONAL, CALIBRATION AND SAFETY TESTS PERFORMED AS PER THE SERVICE MANUAL. THE UNIT PASSED ALL TESTS AND WAS RETURNED TO SERVICE. THIS FIRST FOLLOW-UP REPORT WILL ALSO SERVE AS A FINAL REPORT FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT THE PATIENT EXPIRED DUE TO A HEART FAILURE. THE CUSTOMER STATED THAT THE CARDIOHELP WAS WORKING BUT THE SCREEN WAS FROZEN. THEY INDICATED THAT THE DEATH WAS NOT CAUSED BY THE PERFORMANCE OF THE CARDIOHELP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845092 70104.8012# CARDIOHELP-I CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET MEDICAL SYSTEMS, USA 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1 Death