BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYLOG 3000PLUS

    MDR report key: 16033257 · Received December 22, 2022

    Report

    Report Number
    9611500-2022-00354
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 10, 2022
    Report Date
    February 1, 2023
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K103625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT. H3 OTHER TEXT : ON-GOING.

    Additional Manufacturer Narrative · 0

    THE LOGBOOK OF THE AFFECTED OXYLOG 3000PLUS DEVICE WITH THE SERIAL NUMBER ASCC-0150 WAS AVAILABLE FOR THE INVESTIGATION. IN ADDITION, THE DEVICE WAS EXAMINED ON SITE BY A DRÄGER SERVICE TECHNICIAN ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. NO DEVICE MALFUNCTION WAS DETECTED DURING THE INVESTIGATION. ALSO, NO STOP OF VENTILATION AT THE REPORTED TIME IS DETECTABLE IN THE LOGBOOK. THERE WAS A SHORT TERM DROP IN MV (MINUTE VOLUME) WHICH WAS ALARMED BY THE UNIT AS SPECIFIED WITH "MVE LOW" ALARM (ALARM LIMIT: 4L/MIN). THE SITUATION "MVE < 4L/MIN" OCCURRED ONCE BRIEFLY, CAUSE UNKNOWN, NO FURTHER ALARMS. THE RESULTS OF THE INVESTIGATION DID NOT REVEAL ANY NEW RISKS NOT RECORDED IN THE PRODUCT RISK MANAGEMENT FILE. BASED ON THE INVESTIGATION RESULTS, THE REPORTED EVENT CANNOT BE REPRODUCED. THE EVENT IS ASSESSED BY DRÄGER AS NOT REPORTABLE IN THE SENSE OF THE EUROPEAN MEDDEV 2.12 REV. 8 AND THE MEDICAL DEVICES REGULATION (MDR 2017/745).

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE OXYLOG 3000PLUS DEVICE IN CONCERN WENT OFF 2 TIMES DURING A TRANSPORT. AT THIS POINT IN TIME, THE REPORTED CASE CANNOT BE COMPLETELY REPRODUCED. ALSO, A DEVICE MALFUNCTION OR DEVIATION CANNOT BE EXCLUDED. NO HEALTH CONSEQUENCES OF THE PATIENT WERE REPORTED. IN CASE THE BREATHING PRESSURE (INCL. PEEP) DROPS TO AMBIENT, A DETERIORATION IN STATE OF HEALTH CANNOT BE EXCLUDED FOR PATIENTS WITH DIFFICULT LUNG/VENTILATION CONDITIONS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE OXYLOG 3000PLUS DEVICE IN CONCERN WENT OFF 2 TIMES DURING A TRANSPORT. AT THIS POINT IN TIME, THE REPORTED CASE CANNOT BE COMPLETELY REPRODUCED. ALSO, A DEVICE MALFUNCTION OR DEVIATION CANNOT BE EXCLUDED. NO HEALTH CONSEQUENCES OF THE PATIENT WERE REPORTED. IN CASE THE BREATHING PRESSURE (INCL. PEEP) DROPS TO AMBIENT, A DETERIORATION IN STATE OF HEALTH CANNOT BE EXCLUDED FOR PATIENTS WITH DIFFICULT LUNG/VENTILATION CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858314 OXYLOG 3000PLUS VENTILATORS, TRANSPORT CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown