BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS GSP

    MDR report key: 12703803 · Received October 27, 2021

    Report

    Report Number
    9611500-2021-00440
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 8, 2021
    Report Date
    December 8, 2021
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    PMA / PMN Number
    K011404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL ON-GOING. THE RESULTS WILL BE PROVIDED WITH A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION RESULTS REGARDING THE COMPLAINTS (B)(4) (MDR REPORT NO. 9611500-2021-00427) AND (B)(4) (MDR REPORT NO. 9611500-2021-00440) ARE SUMMARIZED IN THIS LETTER AS THE SAME EVENT HAS OCCURRED TWICE IN SUCCESSION ON THE SAME DEVICE. AFTER THE FIRST OCCURRENCE OF THE FAILURE THE REAL CAUSE WAS NOT DETERMINED DURING INVESTIGATION WITHIN (B)(4) SO THAT THE FAILURE AROSE AGAIN. THEREFORE, A SECOND COMPLAINT (B)(4) WAS OPENED. DURING ON-SITE SERVICE AFTER OCCURRENCE OF THE FIRST EVENT THE LOWER DIAPHRAGM OF THE VENTILATOR WAS FOUND TO BE INSTALLED INSIDE OUT AND WAS ASSESSED AS LIKELY ROOT CAUSE FOR THE REPORTED EVENT. THEREFORE, THE UNIT WAS RETURNED TO CLINICAL USE AFTER REPAIR. LOG ANALYSIS AT MANUFACTURING SITE CONFIRMED AN ISSUE WITH THE VENTILATOR ON THE DATE OF EVENT, (B)(6) 2021. IT COULD BE COMPREHENDED THAT THE SUPERVISOR FUNCTION OF THE SOFTWARE FORCED A SHUTDOWN OF AUTOMATIC VENTILATION AFTER DETECTING A STALLED MOTOR. THIS IS A SAFETY MEASURE TO PREVENT FROM MECHANICAL DAMAGES TO THE VENTILATOR UNIT. THE USER IS ALERTED TO THE SHUTDOWN OF AUTOMATIC VENTILATION BY A CORRESPONDING ALARM; MANUAL VENTILATION REMAINS POSSIBLE AND, THE OTHER DEVICE FUNCTIONS LIKE GAS DOSAGE AND MONITORING REMAIN UNAFFECTED. ON (B)(6) 2021, AGAIN A VENTILATOR FAILURE HAS OCCURRED SO THAT A SECOND COMPLAINT (B)(4) WAS OPENED. THE UNIT WAS SERVICED BY A DRAEGER TECHNICIAN AND THE SAME LOG ENTRIES WERE FOUND AS FOR THE FIRST EVENT- AUTOMATIC VENTILATION WAS STOPPED DUE TO A STALLED MOTOR. ALTHOUGH THE ISSUE COULD NOT BE DUPLICATED ON SITE THE VENTILATOR MOTOR, THE INCREMENTAL ENCODER CABLE, THE LIGHT BARRIER CABLE, AND THE MEMBRANES IN THE VENTILATOR WERE REPLACED AS A PRECAUTIONARY MEASURE. FURTHERMORE, THE TECHNICIAN DETECTED THAT UPON DISASSEMBLY OF THE COMPONENTS THE MOTOR CABLE CONNECTION TO THE CPU BOARD WAS FOUND TO BE NOT SEATED FIRMLY. THE REPLACED PARTS WERE AVAILABLE FOR INVESTIGATION AND WERE ASSEMBLED IN A TEST UNIT WITHOUT SHOWING THE REPORTED FAILURE. FINALLY, THE REPORTED ISSUE COULD BE REPRODUCED BY DETACHING THE VENTILATOR MOTOR CABLE DURING AN ACTIVE VENTILATION. BUT IT WAS NOT POSSIBLE TO DETERMINE WHAT CAUSED THE DETACHMENT OF THE CABLE DURING THE CASE IN QUESTION. AS NO FURTHER SIMILAR CASES ARE KNOWN THE CASE WAS ASSESSED AS A SINGLE EVENT. THE UNIT WAS SUCCESSFULLY TESTED ON SITE AND IS READY FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEAR THE END OF THE FIRST CASE, THE DEVICE ALARMED ¿VENTILATOR FAIL. CHECK APL/EXT. FGO¿. MANUAL VENTILATION WAS USED FOR THE REMAINDER OF THE CASE. NO INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEAR THE END OF THE FIRST CASE, THE DEVICE ALARMED ¿VENTILATOR FAIL!!! CHECK APL/EXT. FGO!!!¿. MANUAL VENTILATION WAS USED FOR THE REMAINDER OF THE CASE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606331 FABIUS GSP ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown