AIRFLOW

Additional Manufacturer Narrative

AN EXTENSIVE AND THOROUGH INVESTIGATION WAS PERFORMED BY THE ENGINEERING TEAM THAT CONCLUDED THE ROOT CAUSE FOR THIS PROBLEM IS THE FACT THAT THE PATIENT PORT AND THE MASK ARE MADE OUT OF SIMILAR BASE MATERIALS RESULTING IN AN UNDESIRABLY HIGH COEFFICIENT OF FRICTION BETWEEN THE TWO PARTS. STEPS HAVE BEEN TAKEN TO IMPLEMENT A MATERIAL COMBINATION WITH A LOWER COEFFICIENT OF FRICTION THAT SIGNIFICANTLY REDUCES THE EFFORT REQUIRED TO REMOVE THE MASK FROM THE PATIENT VALVE.

Description of Event or Problem

THE CUSTOMER ALLEGES "THE BAG CAME APART WHERE THE MASK ATTACHES TO IT." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.