BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY ACS WORKSTATION CC

    MDR report key: 15508849 · Received September 29, 2022

    Report

    Report Number
    9611500-2022-00259
    Event Type
    Death
    Date Received
    September 29, 2022
    Date of Event
    September 13, 2022
    Report Date
    November 22, 2022
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    UDI-DI
    04048675042266
    PMA / PMN Number
    K093633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WAS TESTED BY DRÄGER SERVICE AND THE LOG FILE WAS SECURED FOR DETAILED ANALYSIS. THE LOG ENTRIES SHOW THAT THE VENTILATION WAS ACTIVATED ON (B)(6) 2022, AT 2:30 PM AND HAS BEEN ONGOING UNTIL ON (B)(6). ON THAT DAY THE DEVICE POSTED THE ALARM MESSAGE "DISCONNECTION?" AT 10:15 PM. ADDITIONALLY, THE ANTI-AIR SHOWER FUNCTION WAS ENABLED BY THE USER. WHEN DISCONNECTING THE PATIENT (E.G. DURING A SUCTION) THIS FUNCTION REDUCES THE FLOW AND DISPLAYS FLAT LINED WAVEFORMS UNTIL A RECONNECTION IS DETECTED. THE DISCONNECTION CONTINUOUS UNTIL 11:13 PM. AT 11:25 PM A FURTHER DISCONNECTION WAS ALARMED WHICH CONTINUED UNTIL THE VENTILATION WAS SET INTO STANDBY BY THE USER AT 11:26 PM. AT THAT POINT IT WAS CONFIRMED THAT THE PATIENT WAS TAKEN OFF THE DEVICE. THE LOG FILE DOES NOT CONTAIN ANY INDICATION OF A DEVICE MALFUNCTION DURING THIS PERIOD. DURING THE DEVICE TEST THE VISUAL AND AUDIBLE ALARMS WERE CHECKED TOGETHER WITH THE HOSPITAL¿S BIOMED AND NO MALFUNCTION WAS FOUND. BASED ON THE INVESTIGATION RESULTS THE MISSING AUDIBLE ALARM COULD NOT BE CONFIRMED, AND THE DEVICE REACTED AS SPECIFIED TO A DISCONNECTION IN THE BREATHING CIRCUIT BY POSTING THE CORRESPONDING VISUAL AND AUDIBLE ALARM. THERE IS NO INDICATION THAT THE DISCONNECTION OF THE PATIENT WAS CAUSED BY A DEVICE MALFUNCTION. THEREFORE, WE CONCLUDE THAT THE DEVICE DID NOT CONTRIBUTE TO THE REPORTED PATIENT INJURY. THE INVESTIGATION RESULTS INCLUDING DEVICE BEHAVIOR AND MAINTENANCE RECOMMENDATIONS WERE DISCUSSED AND AGREED WITH THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STAFF HAD FOUND THE UNIT TO HAVE A DISCONNECT ALARM ON THE SCREEN WITH THE PATIENT CONNECTED. IT WAS REPORTED THAT THE PATIENT HAD BEEN IN THIS CONDITION FOR APPROXIMATELY AN HOUR. THE CUSTOMER REPORTED THAT THEY DID NOT HEAR THE UNIT ALARMING. IT HAS BEEN CONVEYED THAT THE PATIENT SUFFERED A BRAIN INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STAFF HAD FOUND THE UNIT TO HAVE A DISCONNECT ALARM ON THE SCREEN WITH THE PATIENT CONNECTED. IT WAS REPORTED THAT THE PATIENT HAD BEEN IN THIS CONDITION FOR APPROXIMATELY AN HOUR. THE CUSTOMER REPORTED THAT THEY DID NOT HEAR THE UNIT ALARMING. IT HAS BEEN CONVEYED THAT THE PATIENT SUFFERED A BRAIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826449 INFINITY ACS WORKSTATION CC VENTILATORS, INTENSIVE CARE CBK DRÄGERWERK AG & CO. KGAA NA NA 04048675042266

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening NA.| NA.