BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACS WORKSTATION NC

    MDR report key: 16351189 · Received February 10, 2023

    Report

    Report Number
    9611500-2023-00057
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 2, 2023
    Report Date
    March 29, 2023
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K093632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED LOG FILE OF THE AFFECTED DEVICE WAS ANALYZED FOR INVESTIGATION. THE LOG FILE ANALYSIS CONFIRMED THAT A COCKPIT RESTART OCCURRED ON (B)(6) 2022. THE CAUSE OF THE COCKPIT RESTART WAS AN OVERLOADED SYSTEM MEMORY DUE TO AN UNUSUALLY LONG OPERATING TIME. BASED ON THE LOG DATA, THE DEVICE HAS NOT BEEN SHUT DOWN SINCE AT LEAST (B)(6) 2022 (292 DAYS OF OPERATION). ACCORDING TO THE LOG ENTRIES, THE UNIT WAS IN STANDBY MODE AT THE TIME OF THE COCKPIT RESTART AND THUS NO VENTILATION WAS ACTIVE. THE LOG FILE ANALYSIS REVEALED THAT THE WARM START OF THE VENTILATION UNIT WAS CAUSED BY THE USER. THE USER SWITCHED OFF THE UNIT VIA THE MAIN SWITCH DURING THE COCKPIT RESTART PROCESS. THE SYSTEM'S SAFETY SOFTWARE ANALYZES AND CHECKS THE PROPER FUNCTIONING OF THE UNIT. IF THE SAFETY SOFTWARE DETECTS A DEVIATION WITH REGARD TO THE INFINITY C500 COCKPIT, A WARM RESTART OF THE COCKPIT IS TRIGGERED TO RESET THE MICROPROCESSING SYSTEM TO A SPECIFIC STATE. VENTILATION IS NOT AFFECTED BY A RESTART OF THE COCKPIT AND CONTINUES AS SET. SAFETY-RELEVANT PARAMETERS SUCH AS FIO2, MINUTE VOLUME OR AIRWAY PRESSURE ARE DISPLAYED IN THE ADDITIONAL YELLOW / GREEN OLED DISPLAY, WHERE THE USER CAN SEE THE ONGOING VENTILATION. AFTER SUCCESSFUL COMPLETION OF THE WARM START, THE SYSTEM SENDS THE ALARM MESSAGE "COCKPIT RESTARTED" WITH THE ASSOCIATED ACOUSTIC ALARM TONE. IF VENTILATION STOPS, THE EMERGENCY VENTILATION VALVE OPENS TO THE ENVIRONMENT TO ALLOW SPONTANEOUS BREATHING. AUDIBLE ALARMS INFORM THE USER OF THE PROBLEM. A PERMANENT HARDWARE MALFUNCTION OF THE COCKPIT CAN NOT BE CONFIRMED BASED ON THE LOG FILE ANALYSIS. ACCORDING TO THE USER MANUAL, THE DEVICE MUST BE RECONDITIONED BEFORE EACH USE. THIS INCLUDES A SHUTDOWN OF THE DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED. BASED ON THE INVESTIGATION RESULTS THIS CASE IS CONSIDERED NOT TO BE REPORTABLE.

    Additional Manufacturer Narrative · 0

    THE INITIAL LOG FILE ANALYSES SHOWED THAT THE COCKPIT AND THE VENTILATION UNIT HAVE PERFORMED A WARM START. THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COCKPIT RESTARTED. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COCKPIT RESTARTED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46375 INFINITY ACS WORKSTATION NC VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown