BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 21034335 · Received December 30, 2024

    Report

    Report Number
    8010042-2024-0002154
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 24, 2024
    Report Date
    December 30, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001110
    PMA / PMN Number
    K201874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION OF THE VENTILATOR WAS REQUESTED. THE HEALTHCARE FACILITY REPORTEDLY INVESTIGATED THE VENTILATOR AND IT FAILED THE INTERNAL LEAKAGE, PRESSURE TRANSDUCER AND FLOW TRANSDUCER TESTS DURING PRE-USE CHECK. THE AIR GAS MODULE WAS REPLACED. THE VENTILATOR THEN PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. THE REPLACED PART WAS NOT RETURNED FOR INVESTIGATION AND NO VENTILATOR LOGS WERE PROVIDED. THE AIR/O2 GAS MODULES REGULATES THE INSPIRATORY GAS FLOW AND A FAULTY AIR/O2 GAS MODULE MAY AFFECT THE DELIVERED VOLUME OR GAS MIXTURE (O2/AIR). SINCE THE REPLACED PART WAS NOT RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED FAILED PRE-USE CHECK HAS NOT BEEN CONCLUSIVELY DETERMINED, BUT THE AIR GAS MODULE WAS MOST LIKELY CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED MULTIPLE TESTS 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
    2428617 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown