BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8845310 · Received July 31, 2019

    Report

    Report Number
    8010042-2019-00559
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Report Date
    July 8, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FSE (FIELD SERVICE ENGINEER) RECEIVED DETAILED INFORMATION FROM RESPIRATOY THERAPIST THAT WAS MANAGING THE VENTILATOR ON THE PATIENT ABOUT THIS EVENT. AT THE TIME OF THE EVENT, THE PATIENT WAS BEING SUCTIONED WHICH CAUSED THE PATIENT TO BE VERY AGITATED. MOST PROBABLY THE PATIENT WAS FIGHTING AGAINST THE VENTILATOR AND POSSIBLY BITING THE ET (ENDOTRACHEAL) TUBE. THIS CAUSED THE VENTILATOR TO GENERATE HIGH PRESSURE AND DROPPED THE TIDAL VOLUME (VT). AFTER THE VENTILATOR WAS PULLED OFF THE PATIENT AND TAKEN TO BIOMED; IT PASSED ALL THE TESTS. THE VENTILATOR IN QUESTION HAS BEEN PLACED BACK IN CLINICAL USE AND FUNCTIONING NORMALLY AT THIS TIME. OUR FSE ALSO INFORMED US THAT THE CUSTOMER DID NOT CONTACT GETINGE FOR THE SAME ISSUE AGAIN. ACCORDING TO RECEIVED EVENT LOGS, VENTILATION PERIOD START AT 14:13:20 ON (B)(6)2019 AND CONTAIN HIGH PRESSURE AND LOW EXPIRATORY ALARMS.THE TECHNICAL LOG DOES NOT CONTAIN ANY ERRORS THAT MAY INDICATE A VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. THE VENTILATOR PASSED PRE-USE CHECK BEFORE AND AFTER THE EVENT. SINCE THE ISSUE DID NOT OCCUR AGAIN AND THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT, MOST PROBABLY THE ALARMS GENERATED DUE TO THE PATIENT CONDITION.

    Description of Event or Problem · 0

    MANUFACTURER REF.#: 227460.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED TO GIVE A BREATH TO THE PATIENT. THERE WAS NO PATIENT HARM. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643129 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1