BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/5 ANESTHESIA MONITOR

    MDR report key: 2820307 · Received October 31, 2012

    Report

    Report Number
    9610105-2012-00041
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 3, 2012
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    CBQ
    PMA / PMN Number
    K002478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE S5 ANESTHESIA MONITOR DID NOT AUDIBLY ALARM FOR A "STRAIGHT LINE" ECG WAVEFORM. THE CLINICIANS WHO WERE PRESENT IN THE OPERATING ROOM AT THE TIME IN QUESTION IMMEDIATELY SAW THE "STRAIGHT LINE" ECG AND RESPONDED TO THE PATIENT'S CONDITION BY PERFORMING CARDIOPULMONARY RESUSCITATION MEASURES. THE PATIENT HAS ANOXIC ENCEPHALOPATHY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 ANESTHESIA MONITOR PATIENT MONITOR CBQ GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR