BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7440313 · Received April 18, 2018

    Report

    Report Number
    8010042-2018-00194
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    April 7, 2018
    Report Date
    May 7, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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

    THE VENTILATOR WAS INVESTIGATED ON-SITE BY OUR FIELD SERVICE ENGINEER. IT RECEIVED SIGNIFICANT DAMAGE BOTH ELECTRONICALLY AND MECHANICALLY AND IS NOT REPAIRABLE. THE VENTILATOR IS TO BE SCRAPPED. THE VENTILATOR OPERATES IN A FIELD OF UP TO 20MT (200 GAUSS) FOR TUNNEL SCANNERS AND UP TO 10MT (100 GAUSS) FOR OPEN SCANNERS. BEFORE USING THE VENTILATOR IN THE MR ENVIRONMENT, CONDITIONS MUST BE MET, INCLUDING LOCKING THE TWO FRONT WHEELS AND PLACING THE VENTILATOR OUTSIDE THE 200 GAUSS (20MT) SAFETY LINE, WHICH MUST BE MARKED AROUND THE MR SCANNER. THESE CONDITIONS ARE STATED IN THE DECLARATION FOR THE USE OF THE VENTILATOR IN THE MR ENVIRONMENT. ACCORDING TO RECEIVED INFORMATION, THE WHEELS OF THE VENTILATOR WERE NOT LOCKED AND THE VENTILATOR WAS ROLLED INTO THE MAGNET ROOM WITH AIR AND O2 TANKS ATTACHED. IT IS NOT KNOWN IF THE VENTILATOR CAME INSIDE THE SAFETY LINE AT THE TIME OF THE EVENT. THE GAUSS SAFETY LINE WAS HOWEVER CORRECTLY MARKED ON THE FLOOR. OUR CONCLUSION IS THAT THE INCIDENT WAS CAUSED BY THE USER NOT FOLLOWING THE REQUIREMENTS FOR USE OF THE VENTILATOR IN MR ENVIRONMENT. 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 PULLED IN TO AN MRI MAGNET WHILE BEING USED ON A PATIENT. 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
    282921 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1