BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 9112512 · Received September 24, 2019

    Report

    Report Number
    8010042-2019-00700
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 19, 2019
    Report Date
    April 30, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR GENERATED ALARMS FOR HIGH PEEP (POSITIVE END EXPIRATORY PRESSURE) AND HIGH CONTINUOUS PRESSURE. OUR FIELD SERVICE ENGINEER CONFIRMED THE ALARMS IN THE DEVICE LOGS BUT COULD NOT FIND ANY TECHNICAL PROBLEM WITH THE VENTILATOR. PRE-USE CHECK PASSED AND THE EXPIRATORY CASSETTE WAS FOUND FAULTLESS. SIMULATED USE TEST VENTILATION DURING 24H PASSED WITHOUT ALARMS OR TECHNICAL ERRORS. NO PART WAS REPLACED. NO FURTHER ISSUES HAVE BEEN REPORTED. THE EVALUATION OF THE RECEIVED DEVICE LOGS CONFIRMS THE REPORTED ALARMS ON THE REPORTED DATE OF EVENT. A SUCTION PROGRAM WAS STARTED AND ACCORDING TO THE DEVICE LOGS THE PATIENT WAS DISCONNECTED AND PERCEIVED RECONNECTED AGAIN ONLY 2 SECONDS LATER. SHORTLY AFTER CLINICAL ALARMS FOR E.G. HIGH AIRWAY PRESSURE, HIGH CONTINUOUS PRESSURE AND HIGH PEEP STARTED TO APPEAR AND DID NOT VANISH BEFORE VENTILATION WAS SET TO STANDBY 17 MINUTES LATER. THE TEST LOG DID NOT INDICATE ANY TECHNICAL PROBLEMS WITH THE VENTILATOR; PRE-USE CHECKS HAD PASSED SUCCESSFULLY, THE LATEST THE EVENING BEFORE THE EVENT AND TWO AFTER VENTILATION WAS STOPPED ON THE DATE OF EVENT. THE REPORTED PROBLEM CAN LEAD TO A HIGHER AIRWAY PRESSURE THAN INTENDED. ALARMS WILL BE GENERATED IF SET ALARM LIMITS ARE EXCEEDED. THE CONCLUSION IN THIS MATTER IS THAT HIGH PRESSURE WAS CONFIRMED IN THE DEVICE LOGS. IT WAS PROBABLY CAUSED BY A KINKED OR BLOCKED TUBING ON THE EXPIRATORY SIDE, FOR EXAMPLE BY A CLOGGED FILTER, BUT THIS COULD NOT BE CONFIRMED. THERE WAS NO INDICATION OF A TECHNICAL FAILURE IN THE VENTILATOR.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: 250158.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE VENTILATOR GENERATED ALARMS FOR HIGH PEEP (POSITIVE END EXPIRATORY PRESSURE) AND HIGH CONTINUOUS PRESSURE. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907450 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1