BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7833033 · Received August 30, 2018

    Report

    Report Number
    8010042-2018-00458
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 28, 2018
    Report Date
    October 18, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 USER FACILITY PERFORMS SERVICE OF THEIR VENTILATORS BY THEMSELVES AND DID NOT REQUEST ANY SERVICE. IT HAS NOT BEEN COMMUNICATED IF ANY PARTS WERE REPLACED. THE INVESTIGATION OF THE PROVIDED VENTILATOR LOGS CONFIRM THE REPORTED EVENT OF ALARMS FOR LOW O2 CONCENTRATION. THE LOGS DO NOT CONTAIN ANY TECHNICAL ERROR CODES THAT INDICATE ANY VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. THE VENTILATOR PASSED PRE-USE CHECK SUCCESSFULLY PRIOR TO THE START OF VENTILATION. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED ALARMS HAS NOT BEEN DETERMINED. 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 WHEN 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
    672585 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1