BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS GS PREMIUM

    MDR report key: 16617109 · Received March 27, 2023

    Report

    Report Number
    9611500-2023-00107
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    February 25, 2023
    Report Date
    March 27, 2023
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    UDI-DI
    04048675041467
    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 ANESTHESIA WORKSTATION INVOLVED IN THIS EVENT WAS IN USE FOR +5 YEARS NOW AND IS NOT UNDER A SERVICE CONTRACT. HENCE, THE LOCAL DRÄGER S&S ORGANIZATION WAS NOT INVOLVED IN EXAMINATION OF THE DEVICE; SERVICE AND MAINTENANCE STATE OF THE UNIT ARE THUS UNKNOWN. UPON CONTACTING THE USER FACILITY TO OBTAIN FURTHER INFORMATION THE BIOMEDICAL ENGINEER COULD NOT PROVIDE A CLEAR FINDING, DEVICE LOG FILES ARE REPORTEDLY NOT AVAILABLE AND, NO ADDITIONAL DETAILS COULD BE PROVIDED. THIS LACK OF INFORMATION DOES NOT ALLOW A CASE-SPECIFIC EVALUATION; NO RELIABLE CONCLUSION ABOUT THE ROOT CAUSE FOR THE EVENT COULD BE MADE. A SHUT-DOWN OF AUTOMATIC VENTILATION MAY OCCUR DUE TO TECHNICAL ISSUES WITH COMPONENTS IN THE VENTILATOR UNIT OR AS A RESPONSE OF THE SAFETY CONCEPT TO OTHER DISTURBANCES - AN EXAMPLE FOR THE LATTER WOULD BE A DISTURBED AIRWAY PRESSURE MONITORING; SINCE THE PROTECTION AGAINST POTENTIALLY HAZARDOUS OUTPUT CANNOT BE ENSURED ANYMORE WHEN AIRWAY PRESSURE MONITORING FAILS, THE DEVICE IS DESIGNED TO SHUT DOWN AUTOMATIC VENTILATION AND TO POST A CORRESPONDING ALARM TO ALERT THE USER. FROM THE ASPECT THAT VENTILATION COULD BE RESUMED AFTER REBOOTING THE DEVICE, A MALFUNCTION IN THE VENTILATOR UNIT IS RATHER TO BE EXCLUDED. A FURTHER DIFFERENTIATION IS HOWEVER NOT POSSIBLE. DRÄGER RECOMMENDED TO HAVE THE DEVICE CHECKED BY A TECHNICAL EXPERT BUT THE DECISION TO USE THE DEVICE FURTHER AS IS IS THE RESPONSIBILITY OF THE OWNER/OPERATOR. DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE SUDDENLY POSTED A "VENT FAIL" ALARM DURING USE. AS PER REPORT, A BIOMEDICAL ENGINEER OF THE HOSPITAL WAS PRESENT - HE RESTARTED THE DEVICE AND, THE SURGICAL PROCEDURE COULD BE FINISHED WITHOUT FURTHER DISTURBANCES. THERE HAVE NO CONSEQUENCES FOR THE PATIENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486288 FABIUS GS PREMIUM ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA NA NA 04048675041467

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown