BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7458308 · Received April 25, 2018

    Report

    Report Number
    8010042-2018-00204
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    March 28, 2018
    Report Date
    July 6, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 AS A PREVENTIVE ACTION THE O2-SENSOR AND THE CONTROL PRINTED CIRCUIT BOARD (PCB) AND RETURNED FOR INVESTIGATION. THE O2-SENSOR MEASURES THE OXYGEN CONCENTRATION TO THE PATIENT. THE CONTROL PCB IS REGULATING THE BREATHING PATTERNS FOR DIFFERENT VENTILATION MODES. THE REPORTED ALARM FOR LOW O2-CONCENTRATION WAS NOT REPRODUCED DURING SIMULATED USE TEST OF THE RETURNED O2-SENSOR AND THE CONTROL PCB IN A REFERENCE VENTILATOR. THE RECEIVED DEVICE LOGS ARE NOT 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

    IT WAS REPORTED THAT WHILE CONNECTED TO A PATIENT, THE VENTILATOR GENERATED ALARMS FOR LOW O2 CONCENTRATION. 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
    305675 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1