VENTSTAR ANESTHESIA

Additional Manufacturer Narrative

THE AFFECTED BREATHING CIRCUIT OF TYPE VENTSTAR ANESTHESIA WF (P) 180 WAS AVAILABLE FOR INVESTIGATION. AS PART OF THE OPTICAL ASSESSMENT, THE REPORTED DISCONNECTION OF THE HOSE AT THE WATER TRAP COULD BE CONFIRMED. A CLOSER LOOK AT THE BREATHING CIRCUIT AND THE WATER TRAP SHOWED THAT ADHESIVE RESIDUES WERE VISIBLE AT THE RESPECTIVE CONNECTION ENDS. IT HAS BEEN REPORTED THAT A LEAKAGE TEST WAS PERFORMED AND PASSED WITH THE AFFECTED BREATHING CIRCUIT BEFORE PATIENT USE. THEREFORE, IT CAN BE CONCLUDED THAT AT THAT TIME THE ADHESIVE CONNECTION WAS STILL INTACT. THE FIRST LEAKS WERE NOTICED SHORTLY AFTER THE START OF THE CASE WHICH WERE ALARMED ACCORDINGLY. CONSEQUENTLY, BETWEEN THE CONDUCT OF THE LEAKAGE TEST AND THE OCCURRENCE OF THE FIRST LEAKS, THERE MUST HAVE BEEN A BREAK-UP OF THE ADHESIVE BOND, WHICH MAY HAVE BEEN CAUSED BY A ROTATION OF THE ADHESIVE SURFACES AGAINST EACH OTHER OR BY ANOTHER MECHANICAL LOAD. SINCE THE AMOUNT OF ADHESIVE USED CAN NO LONGER BE DETERMINED, IT CANNOT BE RULED OUT THAT A POSSIBLY TOO SMALL AMOUNT OF ADHESIVE HAS ALSO HAD A NEGATIVE EFFECT ON THE DURABILITY AND LOAD CAPACITY OF THE CONNECTION. HOWEVER, SINCE AN EVALUATION OF THE LAST 12 MONTHS SHOWED THAT NO OTHER COMPARABLE CASE HAS BEEN REPORTED, A SYSTEMATIC ERROR CAN BE RULED OUT AS A CAUSE. IN CASE OF A RELEVANT LEAKAGE, WHICH CANNOT BE COMPENSATED BY THE CONNECTED MAIN DEVICE, A CORRESPONDING ALARM IS GENERATED, AS REPORTED IN THE PRESENT CASE, TO INFORM THE USER ABOUT THE SITUATION. IN CASE OF A BROKEN ADHESIVE CONNECTION, THERE IS EITHER A COMPLETE DISCONNECTION, WHICH IS IMMEDIATELY VISIBLE, OR THE CONNECTIONS END REMAIN IN A PLUGGED-IN STATE. IN THIS CASE, LEAKS MAY OCCUR IN AREAS WHERE THE SURFACES OF THE CONNECTING ENDS ARE NOT SEAMLESSLY ADJACENT TO EACH OTHER. IN GENERAL, IT IS TO BE EXPECTED THAT THE RESULTING LEAKS ARE IN A RANGE, WHICH CAN BE COMPENSATED BY AN INCREASE OF THE GAS SUPPLY. IF THESE CANNOT BE COMPENSATED OR ELIMINATED, THE HAND BREATHING BAG WHICH MUST BE KEPT ON HAND HAS TO BE USED TO CONTINUE THE VENTILATION. THE PRESENT CASE IS AN ISOLATED CASE. THE INVESTIGATION DID NOT REVEAL ANY NEW RISK.

Description of Event or Problem

PLEASE REFER TO THE INITIAL REPORT.

Additional Manufacturer Narrative

THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

Description of Event or Problem

IT HAS BEEN REPORTED THAT VENTILATING THE PATIENT WAS NOT POSSIBLE DUE TO LEAKAGES. EVEN WITH A CHANGE TO MANUAL VENTILATION, THE LEAKAGE REMAINED PRESENT AND A DROP OF THE OXYGEN SATURATION WAS OBSERVED. USING THE MANUAL RESUSCITATOR, THE VENTILATION HAS STABILIZED AGAIN.