BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE CS2

    MDR report key: 10890882 · Received November 24, 2020

    Report

    Report Number
    2112667-2020-03263
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 23, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K172045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED TO DATE AFTER CALLS TO CUSTOMER 11/16/2020, 11/18/2020, AND 11/23/2020. THE CUSTOMER DECLINED GE SERVICE. NO REPAIR INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A MALFUNCTION RESULTING IN THE OVER DELIVERY OF PRESSURE IN THE PATIENT CIRCUIT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356325 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1009-9050-000

    Patients

    Seq Age Sex Outcome Treatment
    1