BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP SYSTEM

    MDR report key: 4931970 · Received July 22, 2015

    Report

    Report Number
    8010762-2014-00995
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    January 22, 2014
    Report Date
    January 22, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Removal / Correction Number
    Z-0211-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE SERVICE TECHNICIAN WAS CONTACTED ON (B)(6) 2014 AND STATED THAT THERE WAS SOME TIME BETWEEN THE TRAINING CLASSES AND THAT HE SWITCHED OUT THE BATTERIES WITH DIFFERENT ONES AND THAT MADE THE ERROR MESSAGE GO AWAY. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, AT THE (B)(6) MEDIAL CENTER, SAN FRANCISCO, CA DURING A CARDIOHELP TRAINING USING CARDIOHELP UNIT (B)(4) THE CUSTOMER REPORTED THAT THE UNIT ALARMED INDICATING THAT BATTERY 2 NEEDED SERVICE. THE UNIT WAS NOT CONNECTED TO A PATIENT AT THE TIME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476218 CARDIOHELP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1