BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP-I

    MDR report key: 10508201 · Received September 9, 2020

    Report

    Report Number
    8010762-2020-00295
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Report Date
    November 13, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UNDER SERVICE ORDER 43438109 (DATED 2020-08-31) THE SCREWS WERE REINSTALLED. THUS THE FAILURE COULD BE CONFIRMED. FOLLOWING MOST PROBABLE ROOT CAUSE WAS DETERMINED OUT OF THE CARDIOHELP RISK ASSESSMENT (VERSION 22, DMS# 2021972): -MECHANICAL FORCES; -WEAR OF COMPONENTS; -FALL OF DEVICE. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    LOOSE SCREWS INSIDE CARDIOHELP. LOOSE SCREW RATTLING INSIDE. FOUND INVERTER SCREWS TO HMI BOARD-STANDOFF, LOOSE WITH ONE COMPLETELY OUT. REI= NSTALLED SCREWS ON STANDOFF. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974771 CARDIOHELP-I CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1