BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-N

    MDR report key: 8231216 · Received January 9, 2019

    Report

    Report Number
    8010042-2019-00012
    Event Type
    Injury
    Date Received
    January 9, 2019
    Date of Event
    December 20, 2018
    Report Date
    May 10, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4). THE VENTILATOR WAS NOT INVESTIGATED BY OUR FIELD SERVICE ENGINEER BUT VENTILATOR LOGS WERE PROVIDED FROM THE USER FACILITY. THE RECEIVED INFORMATION FORM THE CUSTOMER STATED THAT A HIGHER RESPIRATORY RATE THAN SET IN CONTROLLED VENTILATION MODE WERE DELIVERED DURING THE TIME THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR AND MANUALLY VENTILATED. THE VENTILATOR WAS RETURNED TO US FOR FURTHER INVESTIGATION. INVESTIGATION OF THE VENTILATOR COULD NOT REPRODUCE THE REPORTED HIGH RESPIRATORY RATE OR ANY OTHER DEVIATION. EVALUATION OF PROVIDED VENTILATOR LOGS CONFIRMED THAT HIGH RESPIRATORY RATE ALARMS WERE TRIGGERED. THE HIGH RESPIRATORY RATE ALARMS MAY INDICATE THAT THERE WAS A LEAKAGE IN THE BREATHING CIRCUIT. A LEAKAGE MAY BE PERCEIVED BY THE VENTILATOR AS BREATH TRIGGER FROM THE PATIENT AND THE VENTILATOR WILL THEN INITIATE A SUPPORT BREATH AND THE VENTILATOR STARTS AUTO CYCLING. THIS WILL LEAD TO AN INCREASE IN THE RESPIRATORY RATE. AN AUTO CYCLING CONDITION DUE TO LEAKAGE COULD BE AVOIDED BY INCREASING THE PATIENT EFFORT REQUIRED TO TRIGGER THE VENTILATOR SYSTEM. THE TRIGGER LEVEL SETTING IN THIS CASE IS UNKNOWN SINCE THE LOGS WITH PARAMETER SETTINGS WERE OVERWRITTEN BY NEW LOG POSTS AND NO ADJUSTMENTS IN THE TRIGGER SENSITIVITY WAS MADE DURING VENTILATION COVERED IN THE LOGS. NO TECHNICAL ERROR CODES HAVE BEEN GENERATED TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. PRE-USE CHECK PERFORMED PRIOR AND AFTER EVENT DATE WAS SUCCESSFUL. INFORMATION CONCERNING WHAT TYPE OF PATIENT BREATHING CIRCUIT THAT WAS IN USE WAS REQUESTED BUT COULD NOT BE PROVIDED. OUR CONCLUSION IS THAT THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME OF EVENT AND THE ROOT CAUSE WAS MOST LIKELY A LEAKAGE IN THE PATIENT BREATHING CIRCUIT LEADING TO AN AUTO CYCLING. THE ALARMS FOR HIGH RESPIRATORY RATE WERE CORRECTLY GENERATED ACCORDING TO THE SITUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE PATIENT RECEIVED BRADYCARDIA AND DESATURATION AND WAS SWITCHED TO ANOTHER VENTILATOR. FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24635 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening