BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS PLUS XL

    MDR report key: 19998015 · Received August 16, 2024

    Report

    Report Number
    3019545235-2024-00027
    Event Type
    Malfunction
    Date Received
    August 16, 2024
    Date of Event
    July 29, 2024
    Report Date
    October 2, 2024
    Manufacturer
    SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.
    Product Code
    BSZ
    UDI-DI
    04048675377610
    PMA / PMN Number
    K011404
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE ANESTHESIA SYSTEM HAD A VENTILATION MALFUNCTION DURING USAGE AND COULD NOT BE MECHANICALLY VENTILATED. THE EVENT WAS EVALUATED AS A REPORTABLE EVENT. ACCORDING TO THE HOSPITAL REPORT. AFTER THE MALFUNCTION, THE PATIENT EXPERIENCED RESPIRATORY DISTRESS, DECREASED OXYGEN SATURATION, AND LOWERED BLOOD PRESSURE. MEASURES TAKEN: 1. IMMEDIATELY USE THE MACHINE TO MANUALLY VENTILATE THE PATIENT; 2. FOLLOW THE DOCTOR'S INSTRUCTIONS TO INJECT RELEVANT MEDICATION TO MAINTAIN BLOOD PRESSURE; 3. REPLACE THE NORMAL ANESTHESIA SYSTEM TO CONTINUE WITH THE SURGERY; 4. CLOSELY MONITOR THE PATIENT'S VITAL SIGNS; FINALLY, THE SIGNS BECAME WELL AND THERE WAS NO HARM TO THE PATIENT. THE FIELD ENGINEER HAS PROVIDED REPAIR QUOTES TO THE HOSPITAL, AND WE HAVE NOT RECEIVED ANY FEEDBACK FROM THE HOSPITAL ABOUT THE REPAIR AND RETURN OF THE BAD PARTS. THE INVESTIGATION REPORT WILL BE UPDATED IN TIME IF THERE IS ANY ADDITIONAL INFORMATION ABOUT MAINTENANCE AND FAILURE PARTS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENT FAIL DURING USE, NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENT FAIL DURING USE, NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007325 FABIUS PLUS XL ANESTHESIA UNITS BSZ SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. 8608555 04048675377610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown