BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8577392 · Received May 3, 2019

    Report

    Report Number
    8010042-2019-00301
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 23, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS REPORTED BY THE HOSPITAL. THE HOSPITAL BIOMEDICAL ENGINEER COULD NOT REPRODUCE THE REPORTED PROBLEM AND NO SERVICE MEASURES OR ANY PART WAS REPLACED. NO NEW EVENTS ON THIS VENTILATOR HAVE BEEN REPORTED UNTIL THIS DATE. EVALUATIONS OF THE RECEIVED DEVICE LOGS SHOWS MATCHING EVENT ON THE REPORTED EVENT DAY. BETWEEN (B)(6) 23, AT 15:16 AND 16:35, SEVERAL ALARMS FOR HIGH O2 CONCENTRATION WERE GENERATED. THERE WAS ALSO FOUND HIGH PRESSURE ALARMS IN THE RECEIVED DEVICE LOGS. THE INFORMATION FROM THE CUSTOMER TELLS US THAT AN INJECTOR MODULE OF A NITRIC OXIDE DEVICE AND A FILTER WAS MOUNTED ON THE INSPIRATORY OUTLET ON THE VENTILATOR DURING THE EVENT. WHEN THE FILTER WAS REMOVED ON THE VENTILATOR, THE VENTILATOR WAS AGAIN WORKING AS EXPECTED. A HYPOTHETIC SCENARIO IS THEREFORE THAT THE FILTER HAS CAUSED OSCILLATIONS IN THE OXYGEN GAS MODULE CAUSING THE OXYGEN CONCENTRATION TO BE HIGHER THAN EXPECTED.

    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

    HIGH PRESSURE ALARMS WERE FOUND IN THE DEVICE LOGS THAT WERE RECEIVED. IMPORTER REF. #:(B)(4). MANUFACTURER REF. #: 1917MCC1827.

    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
    373479 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1