BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE

    MDR report key: 3231813 · Received July 15, 2013

    Report

    Report Number
    2112667-2013-00026
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    DATEX-OHMEDA INC.
    Product Code
    BSZ
    PMA / PMN Number
    K092864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST TWO YEARS. REFERENCE MDR 2112667-2012-00035. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED DIFFICULTY PERFORMING A CALIBRATION OF THE ANESTHESIA MACHINE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327772 AESPIRE ANESTHESIA MACHINE BSZ DATEX-OHMEDA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1