BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS TIRO

    MDR report key: 18109404 · Received November 10, 2023

    Report

    Report Number
    9611500-2023-00403
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    October 23, 2023
    Report Date
    August 14, 2024
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    PMA / PMN Number
    K042419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A CORRECTION OF THE PREVIOUS REPORT. THE MODEL NO. WAS CORRECTED. THE USER FACILITY REPORT CONTAINS A SERIAL NUMBER THAT DOES NOT CORRESPOND TO THE FORMAT USED BY DRÄGER. THE SERIAL NUMBER AND UNIQUE DEVICE IDENTIFIER (UDI) OF THE AFFECTED FABIUS TIRO WERE REQUESTED FROM THE CUSTOMER BUT NOT PROVIDED. THEREFORE, THE UDI CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY DID NOT INVOLVE THE LOCAL DRÄGER S&S ORGANIZATION INTO EXAMINATION AND REPAIR OF THE DEVICE. UPON DRÄGER'S REQUEST FOR FURTHER INFORMATION, IT WAS RESPONDED BY THE HOSPITAL THAT NO ADDITIONAL DETAILS CAN BE PROVIDED. A CASE-SPECIFIC EVALUATION IS THUS NOT POSSIBLE. THERE WAS NO S/N INFORMATION TRANSMITTED; AGE OF THE DEVICE AND STATUS OF PREVENTIVE MAINTENANCE AND REPAIRS IS NOT KNOWN TO THE MANUFACTURER. IN FACT, IT CAN EVEN NOT BE CONFIRMED THAT A DEVICE MALFUNCTION OCCURRED - THE REPORTED SCENARIO COULD ALSO BE EXPLAINED BY A LOSS OF MAINS POWER DUE TO E.G. INFRASTRUCTURE PROBLEMS FOLLOWED BY CONTINUED DEVICE OPERATION ON INTERNAL BATTERY UNTIL THE LATTER WAS DEPLETED. A LOT OF OTHER EXPLANATIONS MAY APPLY AS WELL AND, IT IS IMPOSSIBLE FOR DRÄGER TO DIVIDE IF THE REPORTED ISSUE WAS RELATED TO LACK OF PREVENTIVE MAINTENANCE AND REPAIRS, MALFUNCTION, USE ERROR OR INFRASTRUCTURE PROBLEMS OR A COMBINATION OF TWO OR MORE FACTORS. THE DEVICE DESIGN ALLOWS TO BRIDGE PATIENT SUPPORT IN MANUAL VENTILATION WITH THE BUILT-IN BREATHING BAG. THIS HAS OBVIOUSLY WORKED AS INTENDED INCE NO PATIENT CONSEQUENCES HAVE OCCURRED. IT IS RECOMMENDED TO HAVE THE DEVICE CHECKED BY TRAINED SERVICE PERSONNEL. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR EVALUATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISPLAY OF THE ANESTHESIA WORKSTATION SUDDENLY TURNED BLACK AND THAT REBOOTING THE DEVICE COULD NOT REMEDY THE ERROR CONDITION. AS PER REPORT THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISPLAY OF THE ANESTHESIA WORKSTATION SUDDENLY TURNED BLACK AND THAT REBOOTING THE DEVICE COULD NOT REMEDY THE ERROR CONDITION. AS PER REPORT THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93356 FABIUS TIRO ANESTHESIA UNIT BSZ DRÄGERWERK AG & CO. KGAA 8606000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown