BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 18383856 · Received December 22, 2023

    Report

    Report Number
    8010042-2023-02553
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    December 7, 2023
    Report Date
    December 22, 2023
    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

    **DEVICE RELATED DATA QUALITY UPDATES ONLY** A CORRECTION OF FIELDS # D1 BRAND NAME AND # D4 VERSION OR MODEL # WERE REQUIRED. D1 ¿ BRAND NAME - PREVIOUS BRAND NAME: SERVO-S, CORRECTED BRAND NAME: SERVO-S BASE UNIT D4 ¿ VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: SERVO-S, CORRECTED VERSION OR MODEL #: 6640440. 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. THE INTERNAL LEAKAGE TEST AND PRESSURE TRANSDUCER TEST FAILED DURING ON-SITE VISIT. THE AIR GAS MODULE WAS REPLACED. THE ISSUE HAS BEEN RESOLVED AND THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. THE AIR GAS MODULE REGULATES THE INSPIRATORY GAS FLOW AND GAS MIXTURE. THE FAULTY GAS MODULE MAY LEAD TO STOP OF VENTILATION, LOW O2 OR HIGH PRESSURE. OUR CONCLUSION IS THAT THE REPLACED PART WAS THE CAUSE OF THE FAILURE. IN ORDER TO CONDUCT FURTHER ANALYSIS OF THE CASE, MORE DETAILED INFORMATION IS REQUIRED. UNFORTUNATELY, NEITHER THE DEVICE'S LOGS NOR THE CLAIMED PART WERE AVAILABLE FOR FURTHER ANALYZE. THEREFORE, THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF. #: 942215.

    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 AND SAFETY VALVE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290347 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown