BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8297125 · Received February 1, 2019

    Report

    Report Number
    8010042-2019-00058
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 28, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 PERON: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED NOISE AND HIGH PRESSURE. OUR FIELD SERVICE ENGINEER FOUND ISSUES CONCERNING THE EXPIRATORY EASSETTE AND REPLACED THE EXPIRATORY CASSETTE MEMBRANE AND GAS MODULE NOZZLES FROM THE 5000 HOURS MAINTENANCE KIT. NO FURTHER ISSUES HAVE BEEN REPORTED. NO PART WAS RETURNED. THE EVALUATION OF RECEIVED DEVICE LOGS SHOWS SEVERAL CLINICAL ALARMS ON THE REPORTED DATE OF EVENT. SEVERAL OF THEM INDICATE A HIGH EXPIRATORY PRESSURE BUT ALSO LEAKAGE, HIGH RESPIRATORY RATE AND LOW EXPIRATORY MINUTE VOLUME. ANY ERROR RELATED TO THE EXPIRATORY CASSETTE WAS NOT FOUND IN THE DEVICE LOGS. THE REPORTED NOISE MAY COME FROM THE GAS MODULE NOZZLES, BUT THIS CANNOT BE CONFIRMED. HIGH PRESSURE MAY LEAD TO INJURY AND STOP OF VENTILATION. LEAKAGE MAY LEAD TO STOP OF VENTILATION. ALARMS WILL BE GENERATED IF SET ALARM LIMITS ARE EXCEEDED. THE CONCLUSION IS THAT OUR FIELD SERVICE ENGINEER FOUND ISSUES WITH THE EXPIRATORY CASSETTE. THE EXPIRATORY CASSETTE MEMBRANE AND GAS MODULE NOZZLE UNITS WERE REPLACED WHICH RESOLVED THE ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED NOISE AND HIGH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT. IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (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
    88501 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1