BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBK

    MDR report key: 4912006 · Received July 10, 2015

    Report

    Report Number
    8010042-2015-00297
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. NO PART WAS RETURNED AND NO DEVICE LOGS WERE RECEIVED DESPITE SEVERAL REMINDERS. OUR FIELD SERVICE ENGINEER WAS DISPATCHED TO THE HOSPITAL FACILITY TO TROUBLESHOOT THE DEVICE. HE CONFIRMED THE REPORTED ISSUE WITH A TECHNICAL ERROR CODE INDICATING DISABLED VALVES AND STOP OF VENTILATION. HE REPLACED THE DEFECTIVE CONTROL PRINTED CIRCUIT (PC) BOARD ACCORDING TO THE RECOMMENDATION IN THE SERVICE MANUAL, SUCCESSFULLY RAN A PRE-USE CHECK AND RETURNED THE VENTILATOR BACK TO SERVICE. IF THE UNDERLYING DEFECT RESULTING IN DISABLED VALVES OCCURS DURING VENTILATION, VENTILATION WILL STOP AND THE USER WILL BE NOTIFIED TO THE USER BY A GENERATED HIGH PRIORITY ALARM AND THE CORRESPONDING TECHNICAL ERROR CODE. IF THE FAILURE APPEARS DURING STARTUP, THE TECHNICAL ERROR CODE FOR DISABLED VENTILATION WILL BE GENERATED AND VENTILATION CANNOT BE STARTED. THE CONCLUSION IN THIS METER IS THAT THE REPORTED ISSUE WAS CAUSED BY A DEFECTIVE CONTROL PC BOARD. THE CAUSE OF THE DEFECTIVE CONTROL PC BOARD COULD NOT BE DETERMINED SINCE NO PARTS WERE RETURNED AND NO DEVICE LOGS WERE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A VENTILATOR WAS CONNECTED TO A PATIENT, IT GENERATED A TECHNICAL ERROR CODE INDICATING DISABLED VALVES. THE VENTILATOR WAS REPLACED WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448916 CBK SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1