BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 20810233 · Received November 29, 2024

    Report

    Report Number
    8010042-2024-0001969
    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 VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER. THE NOZZLE UNITS IN THE GAS MODULES WERE REPLACED BUT NOT RETURNED FOR INVESTIGATION. NO DEVICE LOGS WERE PROVIDED. THE NOZZLE UNIT IS A 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. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED FAILED PRE-USE CHECK HAS NOT BEEN DETERMINED, BUT THE NOZZLE UNITS WERE MOST LIKELY CONTRIBUTING TO THE EVENT.

    Additional Manufacturer Narrative · 0

    THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF UDI IN MANUFACTURING ON 10/22/2015.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK WITH A MESSAGE 'SYSTEM VOLUME TOO SMALL'. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 1173080.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2439802 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown