BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS

    MDR report key: 5063827 · Received September 9, 2015

    Report

    Report Number
    9611500-2015-00196
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 10, 2015
    Report Date
    September 18, 2015
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K011404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBMITTED ELECTRONIC DEVICE LOG FILE, THE REPLACED POWER SUPPLY AND TWO RECHARGEABLE BATTERIES WERE ANALYSED BY THE MANUFACTURER. ACCORDING TO THE LOG SEVERAL ENTRIES INDICATING AN AC POWER FAIL WERE FOUND DURING THE CASE IN QUESTION. ADDITIONALLY THE FABIUS GS ALARMED SEVERAL TIMES FOR BATTERY LOW!! MEANING THAT THE CAPACITY OF THE BATTERY DROPPED BELOW 10%. FURTHER ENTRIES INDICATED THAT THE MOTOR VOLTAGE HAS DROPPED BELOW 21V WHICH IS REQUIRED FOR AUTOMATIC VENTILATION. THIS LEAD TO THE REPORTED SHUT DOWN OF THE MACHINE. THE POWER SUPPLY WAS FOUND TO BE NON-FUNCTIONAL AS NO DC OUTPUT COULD BE MEASURED DURING TESTING. AS THE POWER SUPPLY IS ALREADY 10 YEARS OLD IT IS IMAGINABLE THAT THE FAILURE WAS CAUSED BY AGING OF INTERNAL ELECTRONIC PARTS. THE RECHARGEABLE BATTERIES WERE FOUND TO BE FUNCTIONAL AFTER RECHARGING. IN CASE OF A AC POWER SUPPLY FAILURE THE FABIUS GS SWITCHES TO BATTERY SUPPLY AUTOMATICALLY SO THAT THE CASE CAN BE CONTINUED USING BATTERY POWER. A CHECK IF THE BATTERY IS FULLY CHARGED IS PART OF THE PRE-USE CHECK DESCRIBED IN THE INSTRUCTION FOR USE AND MUST BE CARRIED OUT BEFORE EACH PATIENT USE. AS APPARENTLY THE BATTERY WAS NOT CHARGED BEFORE THE CASE IN QUESTION THE ROOT CAUSE OF THE REPORTED SHUT DOWN OF THE MACHINE IS A NON-FUNCTIONAL POWER SUPPLY IN COMBINATION WITH DISCHARGED BATTERIES. IN ANY CASE, MANUAL VENTILATION REMAINS UNAFFECTED. THE AFFECTED POWER SUPPLY AND THE TWO RECHARGEABLE BATTERIES WERE REPLACED ON SITE AND THE FABIUS GS WAS RETURNED TO USE WITHOUT FURTHER PROBLEMS REPORTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT HAS NOT YET BEEN CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW UP-REPORT.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MACHINE SHUT DOWN DURING A CASE. THE MACHINE WAS SWAPPED OUT AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595636 FABIUS ANESTHESIA MACHINE CBK DRAEGER MEDICAL GMBH GS NA

    Patients

    Seq Age Sex Outcome Treatment
    1