BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 20810235 · Received November 29, 2024

    Report

    Report Number
    8010042-2024-0001968
    Event Type
    Malfunction
    Date Received
    November 29, 2024
    Date of Event
    November 21, 2024
    Report Date
    November 29, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    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

    THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.

    Additional Manufacturer Narrative · 0

    ON-SITE INVESTIGATION WAS PERFORMED BY OUR FIELD SERVICE ENGINEER. ACCORDING TO THE RECEIVED SERVICE REPORT THE NOZZLE UNITS WERE DEFECTIVE AND IN NEED OF REPLACEMENT. REPLACEMENT OF THE DEFECTIVE PARTS SOLVED THE ISSUE. NO LOG FILES HAVE BEEN PROVIDED. THE PLASTIC NOZZLE UNIT CONTAINS A VALVE DIAPHRAGM. THE VALVE DIAPHRAGM, CONTROLLED BY THE INSPIRATORY SOLENOID, REGULATES THE GAS FLOW THROUGH THE GAS MODULE. THE COMPLETE PLASTIC NOZZLE UNIT MUST BE REPLACED DURING PREVENTIVE MAINTENANCE THE REPLACED PARTS HAVE NOT BEEN RETURNED FOR INVESTIGATION. ACCORDING TO THE RECEIVED INFORMATION, THE CAUSE OF THE ISSUE HAS BEEN DETERMINED AND WAS RELATED TO DEFECTIVE NOZZLE UNITS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR HAD A LEAKAGE NOTICED WHILE IT WAS IN STANDBY MODE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 1173065

    Description of Event or Problem · 0

    MANUFACTURER REF#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2439804 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown