BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 18047799 · Received November 1, 2023

    Report

    Report Number
    8010042-2023-02113
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    October 17, 2023
    Report Date
    November 1, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001110
    PMA / PMN Number
    K201874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON-SITE BY OUR FIELD SERVICE ENGINEER. THE REPORTED EVENT COULD NOT BE DUPLICATED AND THE VENTILATOR PASSED PRE-USE CHECKS. NO PARTS WERE REPLACED AND THE VENTILATOR WAS CLEARED FOR CLINICAL USE. VENTILATOR LOGS WERE DOWNLOADED AND REVIEWED. THE EVENT REPORTEDLY OCCURRED (B)(6) 2023. THE INVESTIGATION OF THE PROVIDED EVENT LOG, SEVERAL CLINICAL ALARMS WERE GENERATED INDICATED AN INCREASED EXPIRATORY RESISTANCE IN THE PATIENT¿S BREATHING SYSTEM, SUCH AS BLOCKED BACTERIA FILTER OR MUCUS OR SECRETION IN THE ENDOTRACHEAL TUBE OR PATIENT AIRWAYS, HOWEVER THIS HAS NOT BEEN DETERMINED. INFORMATION CONCERNING WHAT TYPE OF PATIENT BREATHING CIRCUIT OR FILTER THAT WAS IN USE AT THE TIME WAS NOT PROVIDED. TECHNICAL LOG DOES NOT CONTAIN ANY TECHNICAL ERROR CODES TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. OUR CONCLUSION BASED ON EVALUATION OF THE VENTILATOR LOGS AND THAT NO FAULT WAS FOUND DURING INVESTIGATION OF THE VENTILATOR IS THAT THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 0

    **DEVICE RELATED DATA QUALITY UPDATES ONLY** A CORRECTION OF FIELDS # D1 BRAND NAME, # D4 VERSION OR MODEL #, # D4 UNIQUE IDENTIFIER (UDI) # AND H4 MANUFACTURE DATE WAS REQUIRED. D1 - BRAND NAME: - PREVIOUS BRAND NAME: SERVO-U, - CORRECTED BRAND NAME: BASE UNIT SERVO-U D4 - VERSION OR MODEL #: - PREVIOUS VERSION OR MODEL #: SERVO-U, - CORRECTED VERSION OR MODEL #: 6694800 D4 ¿ UNIQUE IDENTIFIER (UDI) #: - PREVIOUS UNIQUE IDENTIFIER (UDI) #: MISSING - CORRECTED UNIQUE IDENTIFIER (UDI) #: (B)(4). H4 ¿ MANUFACTURE DATE: - PREVIOUS MANUFACTURING DATE: MISSING - CORRECTED MANUFACTURING DATE: 02/20/2021

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR DID NOT VENTILATE AS EXPECTED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF.#: 911170.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198818 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown