BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBK

    MDR report key: 4911999 · Received July 10, 2015

    Report

    Report Number
    8010042-2015-00296
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 17, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE COMPLAINT HAS BEEN COMPLETED. IT IS BASED ON AN EVALUATION OF RECEIVED DEVICE LOGS AND AN INVESTIGATION OF THE RETURNED CONTROL PRINTED CIRCUIT (PC) BOARD AND MONITOR PC BOARD. EVALUATION OF RECEIVED DEVICE LOGS CONFIRMS A SINGLE OCCURRENCE OF THE REPORTED TECHNICAL ERROR CODES AND A STOP OF VENTILATION ON THE DAY OF THE EVENT WHILE ON A CHILD PATIENT. THE TECHNICAL ERROR CODES INDICATED DISABLED VALVES AND A CONTROL PC BOARD COMMUNICATION FAILURE WITH THE MONITOR PC BOARD. SIMULATED USE TESTS CONFIRMED THE REPORTED PROBLEM. THE FAULT CONDITION WAS HOWEVER, NOT PERMANENT AND IT WAS POSSIBLE TO RE-START VENTILATION. STRESS TESTS WERE CONDUCTED WHERE THE CONTROL PC BOARD WAS EXPOSED TO MECHANICAL PRESSURE, COOLING, AND WARMING. ONLY ONCE A FAILURE WAS PROVOKED. IF THE UNDERLYING DEFECT APPEARS DURING VENTILATION, VENTILATION WILL STOP AND THE USER WILL BE NOTIFIED TO BY A GENERATED HIGH PRIORITY ALARM AND THE CORRESPONDING TECHNICAL ERROR CODE. IF THE FAILURE APPEARS DURING START-UP A TECHNICAL ALARM WILL BE GENERATED AND VENTILATION CANNOT BE STARTED. OUR CONCLUSION IN THIS MATTER IS, THAT THE RETURNED CONTROL PC BOARD HARDWARE WAS FAULTY AND WAS THE CAUSE FOR THE REPORTED FAILURE, BUT THE FAILING COMPONENT HAS NOT BEEN IDENTIFIED. NO SIGNS OF A MALFUNCTION ON THE MONITOR PC BOARD APPEARED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENTILATION STOPPED WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT AFTER GENERATING TWO TECHNICAL ERROR CODES. ONE INDICATING DISABLED VALVES AND THE OTHER A COMMUNICATION FAILURE BETWEEN MONITORING AND BREATHING SUBSYSTEMS. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448767 CBK CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1