BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 21630049 · Received March 18, 2025

    Report

    Report Number
    8010042-2025-0000431
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    June 28, 2024
    Report Date
    March 18, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001127
    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

    BASED ON TECHNICIAN STATEMENT, THERE WAS CONTINUOUS GAS FLOW THROUGH INSPIRATORY SECTION DUE TO MALFUNCTION OF THE NOZZLE UNITS ON BOTH GAS MODULES. THEIR REPLACEMENT SOLVED THE ISSUE. THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. THE NOZZLE UNIT IS PART OF THE GAS MODULE AND REGULATES THE INSPIRATORY GAS FLOW TO THE PATIENT. IT CONSISTS OF A MEMBRANE, A MOUTHPIECE AND A FEATHER SPRING. THE MEMBRANE IN THE NOZZLE UNIT IS PRESSED AGAINST A MOUTHPIECE WITH A FEATHER SPRING TO REGULATE THE GAS FLOW THROUGH THE GAS MODULE. ACCORDING TO THE MANUFACTURER'S GUIDELINES, THE PREVENTIVE MAINTENANCE OF THE SYSTEM MUST BE PERFORMED BY AUTHORIZED PERSONNEL AT LEAST ONCE A YEAR, OR EVERY 5000 HOURS OF OPERATION, WHICHEVER COMES FIRST. ONE OF THE PARTS WHICH MUST BE REPLACED IN ORDER TO KEEP THE VENTILATOR FUNCTION SAFE FOR THE PATIENTS ARE NOZZLE UNITS, WHICH ARE ALSO INCLUDED IN MAINTENANCE KIT 5000 HOURS. IT IS ESSENTIAL TO REPLACE NOZZLE UNIT AS SPECIFIED IN OUR DEVICE DOCUMENTATION TO AVOID FAILURE OF THE DEVICE. THE DEVICE'S LOGS WERE NOT PROVIDED FOR FURTHER ANALYSIS. THE LAST TIME PM KIT (INCLUDING NOZZLE UNITS) WERE REPLACED IN 2021. THE CAUSE OF THE CLAIMED ISSUE IN THIS CUSTOMER PRODUCT COMPLAINT HAS BEEN DETERMINED. THE ISSUE WAS RELATED TO DEFECTIVE NOZZLE UNITS, WHICH WERE IMPROPERLY MAINTAINED. A CORRECTION OF FIELD # H6 HEALTH EFFECT ¿ IMPACT CODES WAS REQUIRED. H6 - HEALTH EFFECT ¿ IMPACT CODES - PREVIOUS HEALTH EFFECT ¿ IMPACT CODES: NO HEALTH CONSEQUENCES OR IMPACT///2199, CORRECTED HEALTH EFFECT ¿ IMPACT CODES: NO PATIENT INVOLVEMENT///2645.

    Description of Event or Problem · 0

    DURING THE INSPECTION OF THE VENTILATOR, IT WAS REVEALED THAT THE CONTINUOUS GAS FLOW IN STANDBY MODE APPEARED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992900 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440 07325710001127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown