BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE CS2

    MDR report key: 6055712 · Received October 25, 2016

    Report

    Report Number
    2112667-2016-02112
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 25, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K123125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. ATTEMPTS WERE MADE AS FOLLOWS: 10/21/2016 - PHONE, 10/21/2016 - VOICEMAIL, 10/24/2016 - VOICEMAIL. (B)(4). A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE STATED ISSUE. THE ANESTHESIA CONTROL BOARD WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706081 AVANCE CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1