BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 17957221 · Received October 18, 2023

    Report

    Report Number
    8010042-2023-02025
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 18, 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
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. THE REPORTED ISSUE HAS BEEN CONFIRMED DURING EVALUATION OF RECEIVED PROBLEM DESCRIPTION. SERVICE REPORT AND VENTILATOR LOGS WERE NOT PROVIDED. CUSTOMER CONFIRMED THAT THE ISSUE WAS RESOLVED BY THEMSELVES. NO FURTHER INFORMATION IS AVAILABLE. H3 OTHER TEXT: 4117, 4114.

    Additional Manufacturer Narrative · 0

    DEVICE RELATED DATA QUALITY UPDATES ONLY: A CORRECTION OF FIELD # D1 BRAND NAME, # D4 VERSION OR MODEL #. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 902111.

    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
    178751 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown