BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 18129515 · Received November 14, 2023

    Report

    Report Number
    8010042-2023-02207
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 20, 2023
    Report Date
    November 14, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INFORMATION RECEIVED FROM OUR FIELD SERVICE ENGINEER (FSE) THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THE REPORTED ISSUE HAS BEEN CONFIRMED DURING EVALUATION OF RECEIVED PROBLEM DESCRIPTION, SERVICE REPORT AND LOG FILES. MOREOVER, DURING EVALUATION OF THE UPLOADED LOG FILES IT WAS FOUND OUT THAT ALSO FLOW TRANSDUCER TEST WAS FAILING, SEE LOGS-EXTRACTION BELOW. THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER (FSE) WHO FOUND THAT BOTH O2 AND AIR GAS MODULE'S NOZZLE WAS DEFECTIVE. AFTER REPLACEMENT OF THE DEFECTIVE NOZZLES, THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. THE REPLACED GAS MODULE WAS NOT RETURNED TO US FOR FURTHER INVESTIGATION. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED.

    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-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

    IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 921501.

    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
    2028058 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown