BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7846618 · Received September 5, 2018

    Report

    Report Number
    8010042-2018-00462
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 6, 2018
    Report Date
    October 29, 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
    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

    NO SERVICE HAS BEEN REQUESTED BY THE HOSPITAL AND THE VENTILATOR HAS BEEN PLACED BACK IN CLINICAL USE. NO PARTS HAVE REPORTEDLY BEEN REPLACED. NO VENTILATOR LOGS HAVE BEEN PROVIDED. RECOMMENDATIONS HOW TO HANDLE EXPIRATORY PRESSURE SPIKES HAVE BEEN PROVIDED TO THE USER. THE RECOMMENDATIONS INCLUDE ACTIONS SUCH AS REPLACEMENT OF BACTERIA FILTER TYPES AND VENTILATOR MODE CHANGES UPON RECURRENCE. NO INVESTIGATION HAS BEEN POSSIBLE DUE TO REASONS ABOVE, THEREFORE THE ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED BUT IT WAS MOST LIKELY DUE TO NOT OPTIMAL PARAMETER SETTINGS FOR THE ACTUAL PATIENT CONDITION OR AN INCREASED EXPIRATORY RESISTANCE, WHERE ONE POSSIBLE CAUSE IS AN OCCLUDED EXPIRATORY BACTERIA FILTER. 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 THE VENTILATOR WAS CONNECTED TO A PATIENT, EXPIRATORY PRESSURE SPIKES WITH A RUBBING SOUND WAS NOTED. 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
    688033 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1