BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8270361 · Received January 23, 2019

    Report

    Report Number
    8010042-2019-00047
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    January 2, 2019
    Report Date
    April 12, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 (B)(4). CONTACT PERON: (B)(4). NO SERVICE WAS REQUESTED FOR THE REPORTED ISSUE BY THE USER FACILITY. THE VENTILATOR LOGS WERE NOT PROVIDED AND NO PARTS WERE RETURNED FOR OUR INVESTIGATION. THE USER FACILITY REPORTEDLY PERFORMED A PRE-USE CHECK WHICH PASSED AND THE VENTILATOR THEN CONTINUED TO BE IN CLINICAL USE. NO MORE REPORTED ISSUES HAVE BEEN RECEIVED BY US REGARDING THIS VENTILATOR. ALARMS FOR HIGH O2 CONCENTRATION ARE GENERATED WHEN THE O2 CONCENTRATION BECOMES HIGHER THAN THE UPPER ALARM LIMIT WHICH IS SET VALUE +5 VOL%. DUE TO THE LIMITED INFORMATION PROVIDED, NO INVESTIGATION HAS BEEN POSSIBLE. THEREFORE THE ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED.

    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 PERON: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR GENERATED ALARMS FOR HIGH O2 CONCENTRATION. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65420 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1