FDA Adverse Event Malfunction Summary report: N

AVANCE

MDR report key: 2163564 · Received July 11, 2011

Report

Report Number
MW5021329
Event Type
Malfunction
Date Received
July 11, 2011
Date of Event
June 25, 2011
Report Date
July 11, 2011
Manufacturer
GE DATEX OHMEDA
Product Code
BSZ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WI, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

HYPERVENTILATION WITH GE AVANCE ANESTHESIA MACHINE, SOFTWARE VERSION 6.20. A TRAUMA CASE WAS STARTED USING MANUAL VENTILATION AT 9:37 AM. FRESH GAS WAS ADJUSTED (FROM THE DEFAULT OF 100%) TO 60% OXYGEN. TOTAL FLOW WAS ADJUSTED FROM THE DEFAULT OF 6 LITERS PER MINUTE, TO 2 LPM. AT 9:48, MECHANICAL VENTILATION WAS TURNED ON, USING THE VENTILATION MODE OF PRESSURE CONTROL VENTILATION-VOLUME GUARANTEE -PCV-VG-. PEEP WAS ADJUSTED TO 8 CMH2O. THESE DEFAULT SETTINGS WERE NOT CHANGED: TV = 500, I:E = 1:2, PMAX = 40, RISE RATE = 5. NORMALLY, THE BELLOWS WOULD TRAVEL APPROXIMATELY 500 ML, BUT IN THIS CASE, THE BELLOWS TRAVELED TO ITS LIMIT OF 1500 ML. THE EXPIRED TIDAL VOLUME READING CAPTURED BY THE ELECTRONIC RECORD WAS 807 ML FOR THIS MINUTE, AND 1520 FOR THE NEXT MINUTE. ALARMS WERE RECORDED IN THE ALARMS LOG: DELIVERED VOLUME MISMATCH, AND HIGH EXPIR TV, FOLLOWED BY HIGH EXPIR MV. AT 9:51, THE OPERATOR SET THE TIDAL VOLUME TO 120 ML TO TRY TO REDUCE THE DELIVERED TV TO ACCEPTABLE LEVELS. THIS DID NOT RECTIFY THE SITUATION. THE ELECTRONIC RECORD SHOWS AN EXPIRED TV OF 1484. THE OPERATOR SWITCHED TO MANUAL VENTILATION, AND THE FLOW SENSOR MODULE WAS EXCHANGED WITH ANOTHER MODULE. DURING THE TIME THE FLOW SENSORS ARE DISCONNECTED AND WITH MECHANICAL VENTILATION OFF, THE AVANCE AUTOMATICALLY ZEROES THE DIFFERENTIAL PRESSURE TRANSDUCERS. MECHANICAL VENTILATION WAS TURNED ON AGAIN AT 9:53, BUT THE BELLOWS STILL DELIVERED 1500 ML. THE AVANCE ANESTHESIA MACHINE WAS THEN TURNED OFF, TURNED ON AGAIN, AND AFTER THE 50 SECOND BOOTUP, WORKED FINE USING PCV-VG FOR THE MOST OF THE REMAINDER OF THE CASE. THIS INFORMATION IS FROM THE ANESTHESIA CARE PROVIDERS, THE ELECTRONIC RECORD, AND THE AVANCE DATA LOGS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AVANCE ANESTHESIA MACHINE BSZ GE DATEX OHMEDA 1009-9002-000

Patients

Seq Age Sex Outcome Treatment
1