BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS CS2

    MDR report key: 5764719 · Received July 1, 2016

    Report

    Report Number
    2112667-2016-01234
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 2, 2016
    Report Date
    July 1, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K132530
    Removal / Correction Number
    FMI 34075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 02/24/2015. THE RECALL CLASSIFICATION NUMBER IS Z-1381-2016 AND Z-1382-2016. PATIENT INFORMATION CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A CASE, THE UNIT HAD A SOFTWARE FAILURE THE CLINICIAN REPORTEDLY CYCLED POWER AND RESOLVED THE REPORTED COMPLAINT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420007 AISYS CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1