BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 22174402 · Received June 10, 2025

    Report

    Report Number
    8010042-2025-0000875
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 10, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710000823
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON TECHNICIAN STATEMENT, DURING ON-SITE VISIT ADDITIONALLY AIR PRESSURE ALARM AND TOO MUCH AIR PRESSURE AT THE AIR MODULE (MORE THAN 6 BARS) WERE NOTICED. NOZZLE UNIT ON AIR GAS MODULE WAS FOUND DEFECTIVE. NOZZLE UNITS ON BOTH GAS MODULE WERE REPLACED TO SOLVE THE ISSUES. 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 WAS MANUFACTURED IN SEPTEMBER 2024, WHICH CONFIRMS THAT NOZZLE UNITS ARE LESS THAN ONE YEAR OLD. REVIEW OF THE PROVIDED DEVICE'S LOGS CONFIRMED OCCURRENCE OF THE REPORTED ISSUE. THE CAUSE OF THE CLAIMED ISSUE IN THIS CUSTOMER PRODUCT COMPLAINT HAS BEEN DETERMINED. THE ISSUE WAS RELATED TO DEFECTIVE NOZZLE UNIT. THE CORRECTION OF FIELDS B3 DATE OF EVENT AND H6 ADVERSE EVENT PROBLEM - HEALTH EFFECT - IMPACT CODE WAS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. #B3 DATE OF EVENT: PREVIOUS DATE OF EVENT: 05/27/2025. CORRECTED DATE OF EVENT: 05/21/2025. #H6 ADVERSE EVENT PROBLEM - HEALTH EFFECT - IMPACT CODE. PREVIOUS ADVERSE EVENT PROBLEM - HEALTH EFFECT - IMPACT CODE: NO PATIENT INVOLVEMENT///2645 CORRECTED ADVERSE EVENT PROBLEM - HEALTH EFFECT - IMPACT CODE: NO HEALTH CONSEQUENCES OR IMPACT///2199.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. 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
    1632738 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800 07325710000823

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown