BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVINA 300

    MDR report key: 4875126 · Received June 9, 2015

    Report

    Report Number
    9611500-2015-00091
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    April 2, 2015
    Report Date
    June 9, 2015
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K121886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT HAS NOT YET BEEN CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION HAS BEEN ANALYZED. TWO ERROR CODES IN THE DEVICE LOG (70 0005 AND 93 0005) WERE FOUND, WHICH POINT TO A TEMPORARY COMMUNICATION PROBLEM BETWEEN FRONT PROCESSOR AND MAINBOARD. THE DEVICE INTERNAL MONITORING DETECTED THE DATA INCONTINENCE AND TRIGGERED A RESTART TO RESTORE THE DATA BASE FOR VENTILATION. THE RESTART IS THE SPECIFIED BEHAVIOR FOR THE OBSERVED CONDITIONS. AS THE BEHAVIOR WAS NOT REPEATED, IT CAN BE CONCLUDED THAT NO HARDWARE FAILURE HAS CAUSED THE EVENT. ALSO NO SOFTWARE BUG IS KNOWN CONCERNING THIS ISSUE. DURING THE RESTART, WHICH NEEDS LESS THAN 12 SECONDS, THE PATIENT SYSTEM IS OPENED TO ATMOSPHERE TO ALLOW SPONTANEOUS BREATHING. THEREAFTER THE VENTILATION IS CONTINUED WITH THE PREVIOUS SETTINGS. THE DEVICE POSTS ALARM UNTIL THE LOWER ALARM LIMIT FOR MINUTE VOLUME HAS BEEN EXCEEDED AGAIN. IN THE FRAME OF OUR MARKET OBSERVATION THIS INTERNAL COMMUNICATION PROBLEM IS A RARE CASE AND NO FURTHER MEASURES ARE PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR PERFORMED A RESTART DURING USE ON PT. AFTER 8 SECONDS VENTILATION WAS CONTINUED WITH THE PREVIOUS SETTINGS. NO INJURY WAS REPORTED.

    Description of Event or Problem · 1

    PLEASE SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369888 SAVINA 300 VENTILATORS, INTENSIVE CARE CBK DRAGER MEDICAL GMBH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1