SUNMED HOLDINGS LLC

Additional Manufacturer Narrative

A NEAR MISS OCCURRED WHERE POSITIVE PRESSURE WAS DESIRED AND THE VALVE WAS TURNED CLOCKWISE WITH THE EXPECTATION OF INCREASING PRESSURE, HOWEVER THIS LED TO DECREASING PRESSURE IN THE HYPERINFLATION SYSTEM. IF NOT CORRECTED IMMEDIATELY PATIENT WOULD BE IMPACTED AND SERIOUS HARM COULD OCCUR. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

Description of Event or Problem

THE COMMITTEE ON TECHNOLOGY FOR THE ANESTHESIA PATIENT SAFETY FOUNDATION RECEIVED A REPORT REGARDING OUR HYPERINFLATION SYSTEM DESCRIBING THE DESIGN AS COUNTER-INTUITIVE AND THAT IT DOES NOT CONFORM WITH ISO STANDARD RECOMMENDATIONS. A NEAR MISS OCCURRED WHERE POSITIVE PRESSURE WAS DESIRED AND THE VALVE WAS TURNED CLOCKWISE WITH THE EXPECTATION OF INCREASING PRESSURE, HOWEVER THIS LED TO DECREASING PRESSURE IN THE HYPERINFLATION SYSTEM. THE PROBLEM WAS REMEDIED BY QUICK OBSERVATION THAT TO CLOSE THE VALVE, THE VALVE MUST BE TURNED ANTI-CLOCKWISE.