BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE

    MDR report key: 739496 · Received July 13, 2005

    Report

    Report Number
    2112667-2005-00036
    Event Type
    Malfunction
    Date Received
    July 13, 2005
    Date of Event
    June 16, 2005
    Report Date
    July 12, 2005
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    Removal / Correction Number
    2112667-09/23/2005-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO ORAL ATTEMPTS AND ONE WRITTEN ATTEMPT HAVE BEEN MADE TO OBTAIN PATIENT INFORMAITION FROM CONSIGNEE WITHOUT SUCCESSS. IN THE EVENT PATIENT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE MADE.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY NOTED AN INTERNAL LEAK OF OXYGEN. THERE WAS NO REPORTED PATIENT INJURY. DATEX-OHMEDA'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESPIRE ANESTHESIA MACHINE BSZ DATEX-OHMEDA, INC. AESPIRE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *