BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL ELECTRIC MEDICAL SYSTEMS

    MDR report key: 5476561 · Received February 29, 2016

    Report

    Report Number
    MW5060685
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    February 29, 2016
    Report Date
    February 29, 2016
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    A LUMBAR LAMINECTOMY WAS PERFORMED ON THE PT IN THE OPERATING ROOM. AS IS STANDARD FOR THESE CASES, THE PT WAS MOVED FROM THE SUPINE TO PRONE POSITION AFTER INDUCTION AND INTUBATION. THE BLOOD PRESSURE CUFF AND EKG LEADS WERE REMOVED FROM THE PT TO FACILITATE MOVING FROM SUPINE TO PRONE POSITION ON THE OPERATING ROOM BED. THE EKG LEADS AND BLOOD PRESSURE CUFF WERE THEN PLACED ON THE PT AGAIN; 20-25 MINUTES LATER, IT WAS NOTED THAT THE BLOOD PRESSURE CUFF WAS NO LONGER IN 'AUTOMATIC' MODE, AND BLOOD PRESSURE WAS NOT BEING MEASURED DURING THAT TIME. THE ISSUE IS THAT THE BLOOD PRESSURE CUFF AUTOMATICALLY TURNS OFF OF 'AUTOMATIC' MODE AND RETURNS TO 'MANUAL' MODE. THERE IS NO ALARM TO ALERT THE ANESTHESIA PROVIDER THAT BLOOD PRESSURE MEASUREMENTS ARE NOT BEING TAKEN. THE WORD 'MANUAL' DOES APPEAR IN THE BLOOD PRESSURE BOX ON THE MONITOR, HOWEVER, IT IS SMALL AND DIFFICULT TO NOTICE, ESPECIALLY WITH THE HECTIC NATURE OF THE OPERATING ROOM. THIS SEEMS TO BE AN ONGOING PROBLEM AND AN ISSUE THAT OCCURS FREQUENTLY TO ANESTHESIA PROVIDERS. IN CERTAIN CASES, THIS COULD LEAD TO PROLONGED UNDETECTED HYPERTENSION/HYPOTENSION THAT COULD PROVE HARMFUL AND EVEN DEADLY FOR A CERTAIN SUBSET OF PTS. DATES OF USE: 3 HOURS. DIAGNOSIS OR REASON FOR USE: USED TO MONITOR VITALS FOR PTS UNDERGOING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123436 GENERAL ELECTRIC MEDICAL SYSTEMS ANESTHESIA MONITOR BSZ GENERAL ELECTRIC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR