Description of Event or Problem · 1
THERE HAVE BEEN MULTIPLE FAILURES OF THE SAME TYPE WITH THE ANESTHESIA MACHINE PRIMARY DISPLAY ON THE DATEX-OHMEDA, INC. AVANCE ANESTHESIA SYSTEMS. THE PRIMARY DISPLAY BACKLIGHTS HAVE FAILED ON FIVE DIFFERENT MACHINES CAUSING THE DISPLAY TO GO COMPLETELY BLANK. THE USER IS UNABLE TO SEE ANY CONTROLS OR OPERATE THE MACHINES, CAUSING STAFF TO HAVE TO REMOVE THE MACHINE FROM SERVICE. THE FAILURES HAVE BEEN NOTICED PRIOR TO USE BY THE ANESTHESIA PHYSICIANS. THE PHYSICIANS ARE CONCERNED THAT A FAILURE OF THIS DISPLAY DURING A SURGICAL PROCEDURE COULD PUT THE PATIENT AT GREAT RISK, WHILE THE MACHINE IS EXCHANGED FOR ANOTHER. THE PHYSICIAN WILL BE UNABLE TO SEE OR ADJUST ANY GAS FLOWS, AGENT MONITORING, OR MAKE ANY VENTILATOR ADJUSTMENTS BECAUSE THERE ARE NO MANUAL ADJUSTMENTS POSSIBLE ON THIS MODEL OF ANESTHESIA MACHINES. ALL VENTILATOR AND GAS FLOW ADJUSTMENTS ARE ELECTRONICALLY DISPLAYED, AND MANIPULATION OF CONTROLS IS NOT POSSIBLE WITHOUT AN OPERATING PRIMARY DISPLAY. THE BIOMEDICAL DEPARTMENT DETERMINED THAT THE DISPLAY FAILURES ARE THE RESULT OF THE DISPLAY BACKLIGHT INVERTER PRINTED CIRCUIT BOARDS (PCBS). THERE ARE TWO OF THESE INVERTERS IN EACH DISPLAY, AND THE FAILURES SHOW THAT BOTH INVERTER BOARDS FAILED. THE INVERTERS ARE CHECKED FOR OPERATION EVERY SIX MONTHS DURING THE PREVENTATIVE MAINTENANCE OF THE MACHINE. ALL FIVE DISPLAY FAILURES WERE CORRECTED BY REPLACING THE TWO INVERTERS IN THE DISPLAY. BIOMEDICAL HAS ORDERED ADDITIONAL INVERTER PCBS TO PERFORM THESE REPAIRS UNTIL THE MANUFACTURER RESOLVES THE DISPLAY FAILURE PROBLEMS. HOWEVER, THE MANUFACTURER HAS INFORMED US THAT THE INVERTERS ARE CURRENTLY ON LONG TERM BACKORDER (OVER SIX MONTH). IN ADDITION, THEY WILL NO LONGER SUPPORT THIS CURRENT DISPLAY, WHICH IS LESS THAN TWO YEARS OLD, AND WANT US TO AGREE TO PAY THEM FOR A COMPLETE DISPLAY EXCHANGE.