BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS

    MDR report key: 7128136 · Received December 18, 2017

    Report

    Report Number
    MW5074078
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    May 22, 2021
    Report Date
    December 12, 2017
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE ARKON ANESTHESIA MACHINE'S VENTILATOR SHUT DOWN AND THE MACHINE UNEXPECTEDLY ENTERED A "FAILED STATE" MODE. THE ANESTHESIA PROVIDER MANUALLY VENTILATED THE PT AS THE MACHINE WAS REBOOTED. AFTER REBOOTING, THE ANESTHESIA MACHINE RETURNED TO NORMAL FULL OPERATION WITH NO RESULTING PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906747 SPACELABS ANESTHESIA MACHINE BSZ SPACELABS MEDICAL INC. ARKON 99999

    Patients

    Seq Age Sex Outcome Treatment
    1