BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS PLUS

    MDR report key: 18109406 · Received November 10, 2023

    Report

    Report Number
    3019545235-2023-00015
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    October 17, 2023
    Report Date
    December 21, 2023
    Manufacturer
    SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.
    Product Code
    BSZ
    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

    IT WAS REPORTED THAT THE ANESTHESIA MACHINE WAS NOT VENTILATING PROPERLY AFTER THE PATIENT WAS ANESTHETIZED, AND THE MACHINE WAS REPLACED WITH ANOTHER ANESTHESIA MACHINE ON AN EMERGENCY BASIS WITH NO PATIENT HARM. DRÄGER WAS NOTIFIED OF THIS INCIDENT IN THE ADR SYSTEM AND IMMEDIATELY REPORTED IT TO THE MANUFACTURER FOR INVESTIGATION. AS A RESULT OF THE INVESTIGATION, THE HOSPITAL DID NOT CONTACT DRÄGER TO PARTICIPATE IN THE INSPECTION AND REPAIR MEASURES OF THE EQUIPMENT. DRÄGER REQUESTED ADDITIONAL INFORMATION, WHICH WAS NOT PROVIDED BY THE HOSPITAL AND THEREFORE A SPECIFIC ASSESSMENT COULD NOT BE MADE. ACCORDING TO THE REPORT PROVIDED BY THE HOSPITAL, THE MALFUNCTION WAS VENTILTELLER (M23225) WAS FAULTY. THE ANESTHESIA MACHINE WAS MANUFACTURED IN 2011 AND HAS BEEN IN USE FOR 12 YEARS. ITS MAINTENANCE AND USE ARE UNKNOWN, SO IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ACCIDENT. THE ANESTHESIA MACHINE ISSUED AN ALARM TO ALERT THE USER AS DESIGNED, NO INJURIES WERE REPORTED, AND DRÄGER WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT WAS ANESTHETIZED AND FOUND THAT THE ANESTHESIA MACHINE WAS NOT VENTILATING PROPERLY AND WAS URGENTLY REPLACED WITH A DIFFERENT ANESTHESIA MACHINE WITHOUT CAUSING PATIENT HARM. AS A RESULT OF THE INVESTIGATION, THE HOSPITAL DID NOT CONTACT DRÄGER TO PARTICIPATE IN THE INSPECTION AND REPAIR MEASURES OF THE EQUIPMENT. DRÄGER REQUESTED ADDITIONAL INFORMATION, WHICH WAS NOT PROVIDED BY THE HOSPITAL AND THEREFORE A SPECIFIC ASSESSMENT COULD NOT BE MADE. ACCORDING TO THE REPORT PROVIDED TO THE HOSPITAL, THE MALFUNCTION MANIFESTED WAS IN THE FORM OF A CERAMIC DISK FAILURE (VENTILTELLER PART NO.M23225). THE ANESTHESIA MACHINE WAS MANUFACTURED IN 2011 AND HAD BEEN USED FOR 12 YEARS AND CONSIDERING THE WEAR AND TEAR DURING NORMAL USE, THE INCIDENCE OF MAINTENANCE FAILURES MAY INCREASE.ITS MAINTENANCE AND USE WERE UNKNOWN, SO THE ROOT CAUSE OF THE ACCIDENT COULD NOT BE DETERMINED. THE ANESTHESIA MACHINE ISSUED AN ALARM AS DESIGNED TO ALERT THE USER, NO INJURIES WERE REPORTED, AND DRÄGER WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MACHINE WAS NOT ABLE TO VENTILATE PROPERLY AND NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MACHINE WAS NOT ABLE TO VENTILATE PROPERLY AND NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93358 FABIUS PLUS ANESTHESIA UNITS BSZ SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown