BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8715882 · Received June 20, 2019

    Report

    Report Number
    8010042-2019-00424
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    May 18, 2019
    Report Date
    August 30, 2019
    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 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 PESRON: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS EVENT IS A DUPLICATE EVENT ON THE SAME VENTILATOR. THE INVESTIGATION RESULTS AND EVALUATION CODES FOR THIS EVENT ARE THEREFORE CONTAINED IN THE MFR REPORT #:(B)(4) FOR THE EVENT.

    Description of Event or Problem · 0

    THE RECEIVED LOGS INDICATE HIGH PRESSURE ALARMS. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    MANUACTURER REF.#: 213546.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513774 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1