BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8074867 · Received November 15, 2018

    Report

    Report Number
    8010042-2018-00611
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 26, 2018
    Report Date
    November 30, 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

    OUR FSE WAS ON SITE AND PERFORMED ALL THE FUNCTIONAL TESTS. THE VENTILATOR PASSED ALL THE TESTS INCLUDING O2 SENSOR CELL TEST. THE FSE INFORMED US THAT IT IS FOUND OUT THAT THE REPORTED ISSUE WAS THE CONSEQUENCE OF HOSPITAL O2/GAS SUPPLY PROBLEM. THE VENTILATOR HAD NO MALFUNCTION AT THE TIME OF THE EVENT AND WORKED WITHIN SPECIFICATIONS. (B)(4). REF. EXEMPTION #: E2018003. (B)(4). (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VENTILATOR LOG EVALUATION, INSTANCES OF NO VENTILATION DUE TO LOSS OF GAS SUPPLY WAS NOTED. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912809 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1