BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7900

    MDR report key: 5954122 · Received September 15, 2016

    Report

    Report Number
    2112667-2016-01795
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    August 17, 2016
    Report Date
    September 15, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K023366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. ATTEMPTS WERE MADE AS FOLLOWS: 9/13/2016 - PHONE, 9/13/2016 - EMAIL, 9/15/2016 - EMAIL. THE BIOMEDICAL ENGINEER TROUBLESHOT THE REPORTED FAULT WITH GE HEALTHCARE TECHNICAL SUPPORT. THE ADJUSTABLE PRESSURE LIMITING VALVE WAS REPLACED, AND THE UNIT WAS RETURNED TO SERVICE. PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. ATTEMPTS WERE MADE AS FOLLOWS: 9/13/2016 - PHONE, 9/13/2016 - EMAIL, 9/15/2016 - EMAIL. THE BIOMEDICAL ENGINEER TROUBLESHOT THE REPORTED FAULT WITH GE HEALTHCARE TECHNICAL SUPPORT. THE ADJUSTABLE PRESSURE LIMITING VALVE WAS REPLACED, AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE PRESSURE WOULD RISE AND NOT RELEASE DURING A CASE. THE UNIT WAS SWAPPED OUT TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605458 AESTIVA 7900 ANETHESIA MACHINE CBK DATEX-OHMEDA, INC. 1006-9305-000

    Patients

    Seq Age Sex Outcome Treatment
    1