BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7499777 · Received May 9, 2018

    Report

    Report Number
    8010042-2018-00229
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 14, 2018
    Report Date
    July 6, 2018
    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 PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 GAS MODULE, THE AIR GAS MODULE, THE EXPIRATORY CASSETTE, THE CONTROL PRINTED CIRCUIT BOARD (PCB) AND THE MONITORING PCB WERE REPLACED. THE O2 GAS MODULE, THE AIR GAS MODULE, THE EXPIRATORY CASSETTE AND THE CONTROL PCB WERE RETURNED FOR INVESTIGATION. THE CONTROL PCB AND EXPIRATORY CASSETTE WERE REPLACED DURING FIRST VISIT, WHERE AFTER THE PROBLEM REOCCURRED. THEREFORE THE CONCLUSION IS THAT THESE PARTS ARE FAULTLESS THE O2 GAS MODULE AND THE AIR GAS MODULES REGULATE THE INSPIRATORY GAS FLOW TO THE PATIENT. THE EXPIRATORY CASSETTE IS MEASURING THE EXPIRATORY FLOW AND THE CONTROL PCB IS REGULATING THE BREATHING PATTERNS FOR DIFFERENT VENTILATION MODES. THE REPORTED ALARM FOR LOW O2-CONCENTRATION WAS NOT REPRODUCED DURING TEST OF THE RETURNED O2 GAS MODULE, AIR GAS MODULE, EXPIRATORY CASSETTE AND CONTROL PCB IN A REFERENCE VENTILATOR. NO ALARMS WERE GENERATED DURING VENTILATION, NOR ANY DEVIATION DURING TESTS IN THE PRODUCTION TEST SYSTEM. THE DEVICE LOGS ARE CONFIRMING THE REPORTED EVENT. THE REPORTED PROBLEM COULD NOT BE REPRODUCED, THEREFORE THE CAUSE COULD NOT BE DETERMINED IN THIS INVESTIGATION. 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

    THE VENTILATOR'S LOGS THAT WERE RECEIVED FOR A COMPLAINT CONTAINED LOW O2 ALARMS. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342962 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1