BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7900

    MDR report key: 3943806 · Received April 30, 2014

    Report

    Report Number
    2112667-2014-00075
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 2, 2014
    Manufacturer
    DATEX-OHMEDA INC.
    Product Code
    CBK
    PMA / PMN Number
    K023366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF REPORTED EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTEDLY NOTED DURING A CASE THAT THE UNIT PROVIDED VISUAL ALARMS, HOWEVER, AUDIBLE ALARMS WERE NOT FUNCTIONAL. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258469 AESTIVA 7900 ANESTHESIA MACHINE CBK DATEX-OHMEDA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1