BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVINA

    MDR report key: 23825713 · Received December 17, 2025

    Report

    Report Number
    9611500-2025-00700
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    October 16, 2025
    Report Date
    December 17, 2025
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K003068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UFR WAS THE ONLY INFORMATION FOR THIS CASE; THE HOSPITAL DID NOT INVOLVE THE LOCAL DRÄGER S&S ORGANIZATION INTO ANY FOLLOW-UP MEASURES, AND THE CONTACT PERSON NAMED IN THE UFR COULD NOT PROVIDE FURTHER INFORMATION. DRÄGER IS UNABLE TO FULLY UNDERSTAND THE DESCRIPTION, THE FOLLOWING CAN BE DERIVED: IT WAS STATED THAT THE DEVICE POSTED A HIGH-PRIORITY ALARM - THE UNDERLYING CONDITION CAN THUS NOT INCORPORATE A PREVIOUSLY UNIDENTIFIED OR FALSELY ASSESSED RISK. IT CANNOT BE UNDERSTOOD OF WHAT NATURE THE UNUSUAL NOISE WAS WHICH THE USER OBSERVED DURING THE COURSE OF EVENT - "UNUSUAL" MAY BE INTERPRETED IN MANY DIFFERENT WAYS AND IS NOT NECESSARILY RELATED TO A MALFUNCTION OF THE DEVICE ITSELF. IT CAN FURTHER NOT BE DERIVED IF THE RECOMMENDED PRE-USE CHECK WAS PERFORMED OR NOT - REPORTEDLY, THE ISSUE OCCURRED DURING OR IMMEDIATELY AFTER INTUBATION WHICH LIKELY MEANS WHEN THE VENTILATION EPISODE WAS STARTED; A CLEAR INDICATION FOR A POTENTIAL STOP OF VENTILATION IS NOT INCLUDED IN THE UFR. THE MANUFACTURING OF THE DEVICE DATES BACK TO 08/2012, STATUS OF PREVENTIVE MAINTENANCE AND REPAIRS IS NOT KNOWN TO DRÄGER. FURTHER CONCLUSIONS CANNOT BE DERIVED FROM THE VERY FEW AVAILABLE DETAILS. IT IS RECOMMENDED TO HAVE THE DEVICE CHECKED BY TRAINED SERVICE PERSONNEL AND TO HAVE IT REPAIRED UNDER USE OF ORIGINAL DRÄGER SPARE PARTS IF NECESSARY.

    Description of Event or Problem · 0

    DRÄGER RECEIVED AN UFR IN WHICH IT WAS STATED THAT THE VENTILATOR POSTED A HIGH-PRIORITY ALARM AND EMITTED AN UNUSUAL NOISE IN THE MOMENT THE USERS ATTEMPTED TO INTUBATE THE PATIENT. AS PER REPORT, THE PATIENT WAS CONNECTED TO ANOTHER DEVICE THEN. IT WAS FURTHER MENTIONED THAT THE VITAL SIGNS OF THE PATIENT REMAINED STABLE DURING THE COURSE OF EVENT AND THAT NO HEALTH CONSEQUENCES WERE RESULTING FROM IT. THE DEVICE HAS NO UDI AS AN UDI WAS NOT REQUIRED AT THE TIME THE DEVICE WAS MANUFACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336003 SAVINA VENTILATORS, INTENSIVE CARE CBK DRÄGERWERK AG & CO. KGAA 8414000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown