BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 7515021 · Received May 15, 2018

    Report

    Report Number
    8010042-2018-00235
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    April 20, 2018
    Report Date
    June 12, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    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

    WE HAVE REQUESTED LOGS, SERVICE REPORT AND REPLACED PART (IF ANY). WE HAVE NOT RECEIVED ANY OF THE ABOVE. THE HOSPITAL DID NOT REQUEST SERVICE FROM OUR LOCAL ORGANIZATION. BASED ON THE ABOVE INFORMATION, WE ARE UNABLE TO DETERMINE ANY ROOT CAUSE OF THE REPORTED EVENT. 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 THE VENTILATOR WAS INTERMITTENTLY ALARMING FOR HIGH O2 CONCENTRATION WHILE IT WAS CONNECTED TO A PATIENT. IT IS UNKNOWN IF THERE WAS ANY 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
    359214 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1