BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA

    MDR report key: 1885069 · Received October 20, 2010

    Report

    Report Number
    2112667-2010-00048
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 20, 2010
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K973896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING MORNING CHECKOUT, A SITE REPORTEDLY NOTICED A BURNING SMELL, HEARD ARCING SOUNDS, AND SAW SMOKE COMING FROM THE POWER CORD. THE POWER CORD WAS UNPLUGGED AND THE OUTLET WAS REPORTEDLY MELTED. THERE WAS NO REPORT OF INJURY OR PATIENT INVOLVEMENT. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESTIVA ANESTHESIA MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1