BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8010042-2018-00435

    MDR report key: 7804544 · Received August 22, 2018

    Report

    Report Number
    8010042-2018-00435
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Report Date
    October 8, 2018
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4). PROVIDED LOGS WERE REVIEWED. ALARMS FOR LOW EXPIRATORY MINUTE VOLUME, LOW PEEP AND LEAKAGE OUT OF RANGE WAS GENERATED. THESE INDICATE A LEAKAGE SITUATION. THE FIRST REMEDY ACCORDING TO THE USER¿S MANUAL IS TO CHECK THE PATIENT BREATHING SYSTEM. VENTILATION MODE WAS SET TO NIV (NON INVASIVE VENTILATION) PRESSURE CONTROL MEANING THAT THE PATIENT WAS NOT INTUBATED OR TRACHEOTOMIZED (HAD A MASK OR PRONGS). NIV DISCONNECT FUNCTIONALITY WAS SET TO AN ACTIVE LOW FLOW. THE VENTILATOR CAN BE CONFIGURED BY THE USER TO DISABLE THE NIV DISCONNECTION FUNCTIONALITY. THE VENTILATOR WILL THEN CONTINUE TO DELIVER ASSIST EVEN WHEN LEAKAGE IS EXCESSIVE. DISABLE THE NIV DISCONNECTION FUNCTIONALITY IS RECOMMENDED BUT WITH THE ADVICE TO USE EXTERNAL MONITOR TO ENSURE PATIENTS¿ SAFETY. THE USE OF NIV INTERFACE FIXATION, ASSURING CORRECT SIZES OF INTERFACES (BONNET, MASK, NASAL MASK) AND CORRECT POSITIONING OF VENTILATOR CIRCUITS TO AVOID LEAKAGE ARE ADDITIONAL RECOMMENDATION TO TRY TO LOWER THE LEAKAGE. THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. THE VENTILATOR FUNCTIONED AS IT SHOULD UNDER THE PREVAILING CIRCUMSTANCES. THE CAUSE FOR THE REPORTED ALARMS WAS THE MODE OF VENTILATION AT THE TIME, THE CONFIGURATION OF THE VENTILATOR AND THE LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR WAS UNABLE TO VENTILATE THE PATIENT. ANY PATIENT HARM IS UNKNOWN. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: (B)(4).

    Patients

    Seq Age Sex Outcome Treatment
    1