BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8623745 · Received May 20, 2019

    Report

    Report Number
    8010042-2019-00324
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 24, 2019
    Report Date
    January 17, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FSE (FIELD SERVICE ENGINEER) WAS ON-SITE AND INVESTIGATED THE REPORTED ISSUE AND THE ISSUE COULD NOT BEEN DUPLICATED. NO PARTS REPLACED IN THE SYSTEM AND THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND RETURNED TO CLINICAL USE. THE RECEIVED LOGS INCLUDE PEEP (POSITIVE END EXPIRATORY PRESSURE) ALARMS ON EVENT DATE AND THE TECH LOG SHOWS MULTIPLE EXPIRATORY CASSETTE EXCHANGE ACTIVITY (NOT ON EVENT DATE), HOWEVER, TECHNICAL LOGS DO NOT INCLUDE ANY ALARMS THAT MAY INDICATE A VENTILATOR MALFUNCTION ON EVENT DATE. THE VENTILATOR PASSED PRE-USE CHECK BEFORE AND AFTER THE EVENT. FURTHER INFORMATION CANNOT BE OBTAINED FROM HOSPITAL. DUE TO LACK OF INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE IDENTIFIED.

    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. #: 206858.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE VENTILATOR DID NOT MEET SET TIDAL VOLUME DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417321 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1