BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 18010553 · Received October 26, 2023

    Report

    Report Number
    8010042-2023-02074
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    September 28, 2023
    Report Date
    October 26, 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
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    **DEVICE RELATED DATA QUALITY UPDATES ONLY** A CORRECTION OF FIELDS # D1 BRAND NAME, # D4 VERSION OR MODEL # AND # D4 UNIQUE IDENTIFIER (UDI) # WERE 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).

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE HAS BEEN CONFIRMED DURING EVALUATION OF RECEIVED PROBLEM DESCRIPTION AND DEVICE LOG FILES. CUSTOMER DID NOT REQUEST SERVICE. INFORMATION ABOUT THE CURRENT STATUS OF THE VENTILATOR HAS NOT BEEN PROVIDED. CURRENTLY, NO FURTHER INFORMATION IS AVAILABLE. H3 OTHER TEXT : 4117, 4114.

    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 MULTIPLE TESTS DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 902860.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567614 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown