BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE

    MDR report key: 6869475 · Received September 15, 2017

    Report

    Report Number
    2112667-2017-01751
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    August 23, 2017
    Report Date
    September 15, 2017
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORT OF PATIENT INVOLVEMENT. THE CUSTOMER REQUESTED TECHNICAL SUPPORT FROM GE HEALTHCARE. IT WAS RECOMMENDED TO REPLACE THE COMPACT FLASH CARD.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT HAD A SYSTEM FAILURE DURING BOOT-UP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649878 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1