BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 18009769 · Received October 26, 2023

    Report

    Report Number
    8010042-2023-02072
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Report Date
    October 26, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON-SITE INVESTIGATION WAS PERFORMED BY OUR FIELD SERVICE ENGINEER. THE CLAIMED ISSUE WAS REPRODUCED DURING TROUBLESHOOTING. ACCORDING TO RECEIVED SERVICE REPORT, O2 GAS MODULE WAS IDENTIFIED AS DEFECTIVE. THE AIR/O2 GAS MODULE REGULATES THE INSPIRATORY GAS FLOW AND A FAULTY AIR/O2 GAS MODULE MAY AFFECT THE DELIVERED VOLUME OR GAS MIXTURE (O2/AIR). THE REVIEW OF RECEIVED DEVICE'S LOGS CONFIRMS OCCURRENCE OF THE FOLLOWING TEST FAILURES: INTERNAL LEAKAGE TEST, PRESSURE TRANSDUCER TEST, FLOW TRANSDUCER TEST, GAS SUPPLY TEST AND PATIENT CIRCUIT TEST. OUR CONCLUSION IS THAT THE O2 GAS MODULE WAS THE CAUSE OF THE FAILURE. HOWEVER, THE ROOT CAUSE TO WHY THE PART FAILED HAS NOT BEEN ESTABLISHED AS THE DEFECTIVE PART WAS NOT RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    **DEVICE RELATED DATA QUALITY UPDATES ON LY** A CORRECTION OF FIELDS # D1 BRAND NAME AND # D4 VERSION OR MODEL # WERE REQUIRED. D1 ¿ BRAND NAME - PREVIOUS BRAND NAME: SERVO-I, CORRECTED BRAND NAME: SERVO-I BASE UNIT D4 ¿ VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: SERVO-I, CORRECTED VERSION OR MODEL #: 6487800 THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216784 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown