BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS PLUS XL

    MDR report key: 20134771 · Received September 4, 2024

    Report

    Report Number
    3019545235-2024-00029
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 16, 2024
    Report Date
    October 18, 2024
    Manufacturer
    SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.
    Product Code
    BSZ
    UDI-DI
    04048675377610
    PMA / PMN Number
    K011404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE ANESTHESIA MACHINE WAS IN USE WITH MACHINE CONTROL OF THE PATIENT'S RESPIRATION, AND THAT THE ANESTHESIA MACHINE WORKED NORMALLY WHEN OXYGEN DENITRIFICATION WAS GIVEN BY HAND CONTROL. WHEN THE ENDOTRACHEAL TUBE WAS CONNECTED, THE ANESTHESIA MACHINE BEGAN TO ALARM, DISPLAYING ASPHYXIATION PRESSURE, AND IN THE MACHINE-CONTROLLED STATE, THE ANESTHESIA MACHINE HAD ONLY ASPIRATED BREATHS AND NO RESPIRATORY IMAGES, AND THERE WAS NO PATIENT INJURY. BASED ON THE HOSPITAL'S REPORT, THE PATIENT WAS CONVERTED TO HAND-CONTROLLED ASSISTED VENTILATION AND FOUND THAT THE ANESTHESIA MACHINE WAS STILL ONLY SUCTIONING THE WEATHER WITH NO RESPIRATORY SIGNS, AND WAS CHANGED TO A RESPIRATORY CAPSULE TO ASSIST THE PATIENT'S BREATHING, AND THE PATIENT'S VITAL SIGNS REMAINED STABLE, AND THE SURGERY PROCEEDED NORMALLY. AFTER CONFIRMING WITH DRÄGER'S ENGINEERS, 1) DRÄGER'S ENGINEERS HAVE NOT BEEN CONTACTED ABOUT THE FAILURE OF THIS INCIDENT, AND NO BAD PARTS HAVE BEEN REPLACED, SO IT IS NOT POSSIBLE TO PROVIDE EQUIPMENT LOGS; 2) WHEN THE HOSPITAL'S EQUIPMENT MALFUNCTIONS, THE HOSPITAL ROUTINELY CONTACTS THE AGENT'S ENGINEERS FOR FREE TREATMENT, BUT IT DOES NOT REPLACE ANY BAD PARTS, WHICH IS NOT ABLE TO SOLVE THE PROBLEMS THAT HAVE ARISEN; 3) PREVIOUSLY, THE HOSPITAL HAD A JOINT INSPECTION, AND THERE WERE COMMON PROBLEMS WITH THE ANESTHESIA MACHINE EQUIPMENT. VALVE, DIAPHRAGM WEAR OR AGING PHENOMENON, IT IS RECOMMENDED THAT THE HOSPITAL CONSIDER REPLACING THE ANESTHESIA MACHINE MAINTENANCE PARTS. BASED ON THE CURRENT INFORMATION RECEIVED, THE CAUSE POINTS TO INADEQUATE CLEANING, DISINFECTION, AND MAINTENANCE. AFTER PROLONGED USE OF THE ANESTHESIA MACHINE, THE PATIENT'S AIRWAY SECRETIONS ACCUMULATE, CAUSING THE EXPIRATORY VALVE MEMBRANE TO ADHERE TO THE VALVE SEAT, RESULTING IN A BUILDUP OF MULTIPLE INSPIRATORY PHASES DURING AUTOMATIC VENTILATION, LEADING TO A HIGH AIRWAY PRESSURE ALARM. AT THE SAME TIME, ACCORDING TO THE REPORTED INFORMATION, IN THE CASE OF MANUAL VENTILATION (MECHANICAL VENTILATION HAS BEEN PAUSED), THERE IS STILL ONLY INSPIRATION BUT NO EXPIRATION (THE EXPIRATORY VALVE INSIDE THE COSY 2.6 COULD NOT BE FULLY OPENED OR OPENED VERY SMALL DUE TO ADHESION), WHICH INDICATES THAT THE POINT OF FAILURE IS ONLY IN THE COMPACT RESPIRATORY CIRCUIT, AND IT DOES NOT INVOLVE THE MAIN VENTILATOR AND THE MOTOR OR ANY OTHER COMPONENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALARM OF A SUFFOCATION PRESSURE. IN MACHINE-CONTROLLED MODE, THE ANESTHESIA MACHINE ONLY SHOWED INSPIRATION BUT NO BREATHING, NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALARM OF A SUFFOCATION PRESSURE. IN MACHINE-CONTROLLED MODE, THE ANESTHESIA MACHINE ONLY SHOWED INSPIRATION BUT NO BREATHING, NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918676 FABIUS PLUS XL ANESTHESIA UNITS BSZ SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. 8608555 NA 04048675377610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.| NA.