BEUDAMED
    FDA Adverse Event Injury Summary report: N

    70104.8012# CARDIOHELP-I

    MDR report key: 5361238 · Received January 12, 2016

    Report

    Report Number
    8010762-2016-00019
    Event Type
    Injury
    Date Received
    January 12, 2016
    Report Date
    January 16, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 12:23 PM (GMT-5:00) ADDED BY (B)(6) ((B)(4)): (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SERVICE REPORT #(B)(4) THE DEVICE IN QUESTION WAS DISMANTLED AND IT COULD BE DETERMINED THAT THE DISPLAY (HANDLED IN A SEPARATE COMPLAINT: THE DISPLAY FLAT-CABLE CONNECTOR WAS ACCIDENTALLY DAMAGED BY THE INVESTIGATING ENGINEER), THE TOUCHSCREEN, HMI BOARD AND DISPLAY WERE DEFECTIVE. THE DEFECTIVE PARTS WERE REPLACED. THE SYSTEM SOFTWARE WAS RE-INSTALLED AND THE SERVICE SOFTWARE TEST WAS PERFORMED SUCCESSFULLY. THE TOUCHSCREEN CALIBRATION WAS ALSO PERFORMED SUCCESSFULLY. THE CARDIOHELP DEVICE IN QUESTION WAS CHECKED FOR CORRECT OPERATION AND FUNCTIONALITY SUCCESSFULLY. FURTHER INVESTIGATION CONCERNING THE REPORTED TOUCHSCREEN ISSUE IS ADDRESSED UNDER CAPA (B)(4). A SUPPLEMENT MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SERVICE REPORT #(B)(4) THE DEVICE IN QUESTION WAS DISMANTLED AND IT COULD BE DETERMINED THAT THE TOUCHSCREEN, HMI BOARD AND DISPLAY WERE DEFECTIVE. THE DEFECTIVE PARTS WERE REPLACED. THE SYSTEM SOFTWARE WAS RE-INSTALLED FOLLOWING THE REPLACEMENTS. CALIBRATION AND FUNCTIONALITY CHECKS WERE PERFORMED SUCCESSFULLY. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER READY TO BE USED. THE DEFECTIVE PARTS WERE NOT RETURNED TO THE MANUFACTURING FACILITY FOR FURTHER INVESTIGATION. THERE WERE NO ADVERSE EFFECTS FOR THE PATIENT. TOUCHSCREEN ISSUES ARE BEING INVESTIGATED THROUGH CAPA (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCHSCREEN OF THE CARDIOHELP DEVICE IN QUESTION LOST ITS CALIBRATION. WHILE BEING USED ON A PATIENT. THE SCREEN WAS CALIBRATED IN ORDER TO TRY TO RESOLVE THE PROBLEM BUT IT REOCCURRED. WHEN THE FAILURE OCCURRED THE BUTTONS ON THE BOTTOM OF THE TOUCHSCREEN COULD NOT BE PRESSED. ACCORDING TO ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2015 THE DEVICE IN QUESTION WAS SWAPPED WITH A LOANER UNIT FOR THE REMAINDER OF THE TREATMENT. THE DATE OF EVENT IS UNKNOWN SO FAR. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20367 70104.8012# CARDIOHELP-I CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention