BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 16722493 · Received April 12, 2023

    Report

    Report Number
    8010042-2023-00723
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    April 5, 2023
    Report Date
    April 12, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710000823
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT HIGH CONTINUOUS PRESSURE ALARM OCCURRED AND THAT THE VENTILATOR WAS MAKING SOUND. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION AND SERVICE REPORT. ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICIAN, DURING ON-SITE VISIT THE TECHNICIAN CARRIED OUT TROUBLESHOOTING AND STARTED WITH PERFORMING COMPLETE PRE-USE CHECK IN WHICH THE DEVICE FAILED THE INTERNAL LEAKAGE TEST WITH MESSAGE ¿SYSTEM VOLUME TOO LARGE¿, PRESSURE TRANSDUCER TEST, FLOW TRANSDUCER TEST, SAFETY VALVE TEST AND PATIENT CIRCUIT TEST. THE AIR AND O2 GAS MODULES WERE CHECKED AND DUST PARTICLES WERE FOUND IN O2 GAS MODULE. AFTER THE O2 GAS MODULE WITH FILTER WERE CLEANED, THE PRE-USE CHECK PASSED SUCCESSFULLY. DURING FURTHER TROUBLESHOOTING THE DEVICE GENERATED HIGH PEEP ALARM, INDICATING THAT THE PRESSURE ISSUES PERSISTED AND IT WAS CONCLUDED THAT O2 GAS MODULE IS DEFECTIVE AND NEEDS TO BE REPLACED TO RESOLVE THE ISSUE. THE GAS MODULE REGULATES THE INSPIRATORY GAS FLOW AND GAS MIXTURE. THE ISSUE WAS DECIDED TO BE REPORTED AS A DEFECTIVE GAS MODULE MAY LEAD TO STOP OF VENTILATION, LOW O2 OR HIGH PRESSURE. THERE WAS NO PATIENT HARM. THE MOST LIKELY TRIGGER FOR HIGH CONTINUOUS PRESSURE ALARM AND HIGH PEEP ALARM ACTIVATION WERE THE DUST PARTICLES IN O2 GAS MODULE, WHICH MAY INCREASED RESISTANCE AND CAUSE INCREASE IN AIRWAY PRESSURE. IN ORDER TO CONDUCT FURTHER ANALYSIS OF THE CASE, MORE DETAILED INFORMATION IS REQUIRED. UNFORTUNATELY, NEITHER THE DEVICE LOG NOR THE DEFECTIVE PART WERE AVAILABLE FOR FURTHER ANALYZE. THEREFORE, THE EXACT ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED. #H8 USAGE OF DEVICE: PREVIOUS USAGE OF DEVICE: UNKNOWN. CORRECTED USAGE OF DEVICE: REUSE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR MADE NOISE AND ALARMED FOR HIGH CONTINOUS PRESSURE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 802961.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284541 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I 07325710000823

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown