BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7788790 · Received August 16, 2018

    Report

    Report Number
    8010042-2018-00424
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 15, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 (B)(4). CONTACT PERSON: (B)(4). THE EXPIRATORY FILTER WAS EXCHANGED WHEN THE PATIENT EXHIBITED INCREASED EXPIRATORY WORK OF BREATHING. THE EXPIRATORY TUBE FILTER OF ANOTHER BRAND WAS INSPECTED BY THE USER AND FOUND TO BE FULL OF WATER AND DISCARDED. NO PARTS WERE RETURNED. NO DEVICE LOGS HAVE BEEN AVAILABLE FOR OUR INVESTIGATION. FURTHER INFORMATION REGARDING THE FILTER USE WAS REQUESTED. EXPIRATORY TUBE FILTERS ARE ROUTINELY CHANGED ONCE EVERY DAY AND THE FILTER IN QUESTION WAS USED FROM THE DAY BEFORE. IT WAS ALSO INFORMED BY THE USER FACILITY THAT ACTIVE WARMING HUMIDIFICATION OF ANOTHER BRAND WAS USED AND THE TEMPERATURE DISPLAY HAD BECOME HIDDEN BEHIND THE PATIENT BED. THE TEMPERATURE HAD VARIED OVER THE TIME THE FILTER WAS USED AND THIS IS BELIEVED TO HAVE BEEN CREATING THE EXCESS MOISTURE IN THE FILTER. THE USER¿S MANUAL OF THE VENTILATOR INCLUDES A WARNING THAT IF ACTIVE HUMIDIFICATION IS USED, THE USER MUST CAREFULLY MONITOR THE AIRWAY PRESSURE AND CONTINUOUSLY CHECK TO ENSURE THAT POSSIBLE CONDENSATION CREATED IN THE EXPIRATORY SIDE DOES NOT AFFECT VENTILATOR PERFORMANCE. OUR CONCLUSION IS THAT THE ROOT CAUSE OF THE EXPERIENCED PROBLEM IS LACK OF ROUTINE INSPECTION OF THE CONDENSATION CREATED IN THE EXPIRATORY TUBE AND FILTER. THERE IS NO VENTILATOR MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD BEEN ON VENTILATORY THERAPY FOR SEVERAL DAYS. THE PATIENT BREATHED HEAVILY. IT WAS OBSERVED THAT THE EXHALATION TUBE FILTER HAD PLENTY OF WATER WHICH SIGNIFICANTLY INCREASED THE PATIENTS EXPIRATORY RESISTANCE. THE FILTER WAS REPLACED WITH A DRY ONE AND THE PATIENT CALMED DOWN. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629243 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1