BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8627179 · Received May 21, 2019

    Report

    Report Number
    8010042-2019-00327
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    April 27, 2019
    Report Date
    September 26, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    NO SERVICE ON THE VENTILATOR HAS BEEN REQUESTED BY THE USER FACILITY. THE VENTILATOR HAS BEEN RETURNED FOR CLINICAL USE. ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT THE MEDICAL AIR SUPPLY IN THE PATIENT ROOM INTERMITTENTLY WAS DELIVERING A HIGHER O2 CONCENTRATION. PROVIDED VENTILATOR LOGS WERE REVIEWED AND THE ALARMS FOR HIGH O2 CONCENTRATION WERE CONFIRMED. ALARMS FOR HIGH AIRWAY PRESSURE WERE ALSO NOTED. THE TECHNICAL LOG DOES NOT CONTAIN ANY TECHNICAL ERROR CODES THAT INDICATE A VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. THE VENTILATOR PASSED PRE-USE CHECK PRIOR TO THE ACTUAL VENTILATION. THE ROOT CAUSE OF THE ALARMS FOR HIGH O2 CONCENTRATION IS MOST LIKELY THE O2 INACCURACY IN THE MEDICAL AIR SUPPLY. THERE WAS NO VENTILATOR MALFUNCTION.

    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).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: 206753.

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420943 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1