BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 17957223 · Received October 18, 2023

    Report

    Report Number
    8010042-2023-02024
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    October 4, 2023
    Report Date
    October 18, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON-SITE INVESTIGATION WAS PERFORMED BY OUR FIELD SERVICE ENGINEER. IT WAS CLAIMED THAT DEVICE HAD PRESSURE PROBLEMS. BASED ON TECHNICIAN STATEMENT, DESPITE VENTILATOR BEING TURNED OFF, THE GAS WAS SENT TO INSPIRATORY PIPE. THE INSPIRATORY PIPE WAS REPLACED. THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. WE DO NOT CONSIDER ISSUE WITH INSPIRATORY PIPE MALFUNCTION AS A SAFETY RELATED, AS INSPIRATORY PIPE IS A PART IN INSPIRATORY SECTION, WHICH IS ONLY A HOUSING OR CONNECTOR FOR MULTIPLE PARTS AND WILL NOT AFFECT VENTILATION. THE DECISION ABOUT REPORTING WAS MADE IN ABUNDANCE OF CAUTIONS BASED ON THE INITIALLY REPORTED INFORMATION, AS IT MAY REPRESENTING A REPORTABLE EVENT. THE DEVICE'S LOGS WERE NOT PROVIDED FOR FURTHER ANALYSIS, HENCE THE ROOT CAUSE OF THE INSPIRATORY PIPE MALFUNCTION WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 0

    DEVICE RELATED DATA QUALITY UPDATES ONLY: THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015. A CORRECTION OF FIELD # D1 BRAND NAME, # D4 VERSION OR MODEL #. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR HAD PRESSURE PROBLEMS. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 903459.

    Description of Event or Problem · 0

    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
    178753 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown