BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 19213190 · Received April 30, 2024

    Report

    Report Number
    8010042-2024-00714
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 10, 2024
    Report Date
    April 30, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001110
    PMA / PMN Number
    K201874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INFORMATION PROVIDED BY THE TECHNICIAN, OUR TECHNICIAN NEVER WAS ON SITE. NO MORE INFORMATION WAS PROVIDED REGARDING WHICH TECHNICAL ERROR WAS GENERATED, CONTEXT OF THE ISSUE OR THE CAUSED OF THE IT. THE CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE DURING VENTILATION. NO MORE INFORMATION WAS AVAILABLE. THERE WAS NO PATIENT¿HARM. MANUFACTURER'S REF. #: 1020852.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160002 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown