BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATEX-OHMEDA INC

    MDR report key: 394668 · Received May 7, 2002

    Report

    Report Number
    MW1025009
    Event Type
    Malfunction
    Date Received
    May 7, 2002
    Date of Event
    May 6, 2002
    Report Date
    May 7, 2002
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REGARDS OHMEDA AESTIVA ANESTHESIA MACHINES AND THE ATTACHED OHMEDA MONITORING SYSTEM. RPTR HAS HAD MULTIPLE FAILURES WITH THE COMPONENTS OF MACHINES AND MONITORS THAT ARE LESS THAN 6 MOS OLD. RPTR HAS SEEN, PERSONALLY 4 ANESTHESIA VAPORIZER FAILURES, ONE OCCULT LEAK AND THREE INTERMITTENT. NO OUTPUT ALARMS FROM DESFLURANCE TEC 6 VAPORIZERS. THE LATEST FAILURE OCCURRED WHEN RPTR WAS INDUCING PT. THE MONITOR INDICATED RPTR WAS ADMINISTERING 2% WHEN THEY INTENDED TO ADMINISTER 6% DURING OVERPRESSURE INDUCTION. RPTR SMELLED THE CIRCUIT AND IT DID NOT SMELL LIKE 6% EITHER. INCREASING THE FLOW RATES AND DIAL SETTINGS OF THE VAPORIZER INCREASED THE ANESTHETIC CONCENTRATION ONLY SLIGHTLY (LESS THAN 3%), IT THEN FELL SLOWLY AND A NO OUTPUT ALARM WENT OFF. RPTR WOULDN'T BE SURPRISED IF LOW OUTPUT PRECEEDED ALL THE OTHER NO OUTPUT ALARMS. THIS TYPE OF FAILURE CAN LEAD TO INTRAOPERATIVE AWARENESS. THE NONINVASIVE BLOOD PRESSURE IS PRONE TO INTERMITTENT FAILURES. ONE'S FIRST THOUGHT IS THE PT MAY BE PROFOUNDLY HYPOTENSIVE. A CHANGE IN CUFF OR HOSE MAY COINCIDE WITH APPARENT NORMAL OPERATION ONLY TO HAVE A FAILURE RECUR HRS TO DAYS LATER. THE PROBLEM TO RPTR FEELS LIKE A LEAK INTERNALLY IN THE MACHINE. NO LEAK IN THE CUFF CAN BE DEMONSTRATED. THE MACHINES THEMSELVES ARE NOT UP TO THE RIGORS OF MODERN ANESTHESIA PRACTICE, BY THAT RPTR MEANS LONG CASES AND LONG DAYS. THERE WAS A REPORT IN THE LITERATURE ABOUT ACCUMULATED HUMIDITY CREATING ALL SORTS OF VENTILATOR ALARMS. RPTR HAS SEEN THAT AND HAS ALSO HAD UNWANTED POSITIVE END EXPIRATORY PRESSURE IN THE CIRCUIT WHEN USING A VENTILATOR. TO DATE RPTR IS AWARE OF NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA INC AESTIVA ANESTHESIA MACHINE CAD DATEX-OHMEDA, INC. AESTIVA/5 ANESTHESIA MACHINE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other 1) S/5 ANESTHESIA MONITOR.