BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 20365888 · Received October 4, 2024

    Report

    Report Number
    8010042-2024-0001619
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    May 23, 2024
    Report Date
    October 4, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710000823
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO RECEIVED INFORMATION LARGE LEAKAGE OCCURRED, MOST LIKELY RELATED TO PATIENT CIRCUIT, AND NO MALFUNCTION OF THE VENTILATOR HAS BEEN FOUND. THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. REVIEW OF THE DEVICE'S LOGS CONFIRMED OCCURRENCE OF SEVERAL ALARMS. THE EVENT LOGS INDICATE DIFFICULTIES WITH VENTILATING THE PATIENT, BUT THERE ARE NO TECHNICAL ERROR CODES INDICATING A VENTILATOR MALFUNCTION. ALARMS SUCH AS LOW RESPIRATORY RATE, HIGH RESPIRATORY RATE, POSITIVE END EXPIRATORY PRESSURE (PEEP) LOW, INSPIRATORY TIDAL VOLUME OVERRANGE OR EXPIRATORY MINUTE VOLUME LOW INDICATE A LEAKAGE IN THE PATIENT CIRCUIT. ALARMS WILL BE GENERATED WHEN SET ALARM LIMITS ARE EXCEEDED, AS PER DESIGN TO ALERT THE OPERATOR ABOUT ONGOING ISSUES. MOREOVER, IT WAS OBSERVED IN DEVICE'S LOGS THAT INTERNAL LEAKAGE TEST FAILURE AND PRESSURE TRANSDUCER TEST FAILURE OCCURRED ON THE DATE OF EVENT AND PRIOR THE DATE OF EVENT, BUT THESE FAILURES SHOWED ONLY A MINOR LEAKAGE, WHICH COULD NOT BE THE CAUSE OF THE ISSUE. THE TECHNICAL LOG DOES NOT CONTAIN ANY TECHNICAL ERROR CODES TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION. THE CONCLUSION IS THAT THE REPORTED ALARMS OCCURRED DUE TO LEAKAGE, BUT THERE WAS NO TECHNICAL MALFUNCTION OF THE VENTILATOR. THE CAUSE OF THE REPORTED ISSUE HAS BEEN DETERMINED AS MOST LIKELY RELATED TO THE LEAKAGE IN PATIENT CIRCUIT.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR HAD A LEAKAGE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 1132033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325743 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800 07325710000823

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown