BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 5233786 · Received November 18, 2015

    Report

    Report Number
    8010042-2015-01066
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 23, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TROUBLESHOOTING WAS PERFORMED BY THE HOSPITAL'S BIOMED. THERE IS NO INFORMATION IF ANY PARTS WERE REPLACED. ACCORDING TO RECEIVED INFORMATION THE VENTILATOR IS BACK IN CLINICAL SERVICE WITH NO FURTHER PROBLEMS REPORTED. OUR INVESTIGATION COMPRISES OF DEVICE LOG EVALUATION. THE LOGS SHOW THAT PERFORMED PRE-USE CHECK AFTER THE REPORTED EVENT PASSED WITHOUT DEVIATION. THE REPORTED LOW EXPIRATORY MINUTE VOLUMES (MVE) ARE CONFIRMED IN RECEIVED LOGS. HOWEVER THE INFORMATION ABOUT THE VENTILATOR DELIVERING FLOW ONLY FOR PATIENT INITIATED BREATHS AND THAT AT THE TIME THE AUTOMODE WAS NOT ACTIVE, IS NOT CORRECT. THE LOGS SHOWS THAT THE MODE OF VENTILATION AT THE TIME WAS PRESSURE CONTROL (PC) WITH A RESPIRATORY RATE SET TO 14 BREATHS/MINUTE (B/MIN). THE AUTOMODE FUNCTION WAS ACTIVE FOR ONE HOUR WITH A TRIGGER TIMEOUT OF 7 SECONDS. THIS MEANS THAT THE VENTILATOR WOULD START DELIVERING BREATHS WITHIN 7 SECONDS IF THE PATIENT HASN'T TRIGGERED ANY BREATHS. DEPENDING ON THE NUMBER OF PATIENT TRIGGERED BREATHS, THE RESPIRATORY RATE MAY BE LOWER THAN THE SET. ALARMS FOR LOW RESPIRATORY RATE WOULD BE GENERATED IF THE SET ALARM LIMIT IS EXCEEDED. THE LOGS ALSO SHOW A PERIOD OF APPROX. 30 MINUTES OF VENTILATION WITH THE AUTOMODE SWITCHED OFF. DURING THIS TIME ALARMS FOR LOW MVE AND LOW PEEP (POSITIVE END EXPIRATORY PRESSURE) WERE GENERATED. THE CAUSE TO THOSE ALARMS CANNOT BE DETERMINED SINCE NO PARTS WERE RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    NOVEMBER 18, 2015 10:47 AM (GMT-5:00) ADDED BY (B)(6): FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, ITS MEASURED EXPIRATORY VOLUME 1.5 - 3.5 LITERS PER MINUTE WHICH WAS MUCH LOWER THAN THE SET VOLUME. THE RESPIRATORY RATE WAS SET AT 14 BREATHS PER MINUTE BUT THE VENTILATOR WAS ONLY DELIVERING BREATHS ONLY FOR PATIENT INITIATED BREATHS THAT WERE 6-8 BREATHS PER MINUTE. IT WAS FURTHER REPORTED THAT AT THE TIME THE AUTOMODE WAS NOT ACTIVE. THE VENTILATOR WAS REPLACED WITH ANOTHER ONE AND IMMEDIATELY THE EXPIRATORY VOLUMES WERE NORMAL AT 10 LITERS PER MINUTE. DURING AUTOMODE THE VENTILATOR SWITCHES TO A CONTROLLED MODE OF VENTILATION AND DELIVERS CONTROLLED BREATHS WHEN THERE ARE NO PATIENT INITIATED BREATHS. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762287 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1