BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7577989 · Received June 7, 2018

    Report

    Report Number
    8010042-2018-00284
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    June 4, 2018
    Report Date
    September 7, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 GAS MODULE AND THE AIR GAS MODULE WERE REPLACED AND RETURNED FOR INVESTIGATION. THE REPORTED O2 CONCENTRATION HIGH ALARMS WERE NOT REPRODUCED DURING TEST OF THE RETURNED AIR GAS MODULE AND O2 GAS MODULE IN A REFERENCE VENTILATOR. THE OXYGEN GAS MODULE WAS FOUND TO BE OSCILLATING DURING TEST IN THE PRODUCTION TEST SYSTEM FOR GAS MODULES. THE OSCILLATIONS WERE CAUSED BY THE NOZZLE UNIT. WHY THE NOZZLE UNIT FAILED, COULD NOT BE DETERMINED IN THIS INVESTIGATION. THERE HAS BEEN REPORTED TANDEM USE OF A HIGH FREQUENCY JET VENTILATOR (HFJV) WHICH IMPLIES THAT THE HFJV IS CONNECTED TO AN ET TUBE ADAPTER AND IT INDUCES A ¿JET¿ OF GAS OUT OF THE ADAPTER INTO THE AIRWAY. THE MEASURED INSPIRATORY VALUES WOULD BE AS PER SET PARAMETER VALUES BUT THE MEASURED EXPIRATORY VALUES WOULD INCLUDE THE VALUES OF THE HFJV AND THEREFORE THE MEASURED EXPIRATORY VALUES WOULD NOT REFLECT THE PARAMETER SETTINGS AND WILL LEAD TO GENERATION OF APPROPRIATE ALARMS. THE USE OF A HFJV IN TANDEM WITH THE VENTILATOR HAS NOT BEEN TESTED, APPROVED OR RECOMMENDED FOR USE WITH THIS VENTILATOR SYSTEM. THEREFORE THE CONSEQUENCES OF ITS USE WITH OUR VENTILATOR ARE UNKNOWN. THE RECEIVED DEVICE LOG CONFIRMS THE REPORTED PROBLEM. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING VENTILATION, ALARMS FOR HIGH O2 CONCENTRATION WERE GENERATED WHEN THE VENTILATOR WAS USED IN TANDEM WITH A HIGH FREQUENCY JET VENTILATOR (HFJV). THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422926 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1