[19489968]
During a hosp test on 6/9/97 of aircare source control system, an aircare airator and its accompanying aircare adhesive mask was being used on a pt. Soon after mask was applied, pt complained of difficultly in breathing and aircare adhesive mask was immediately removed. Upon examining airator it was discovered that inspiratory relief valve was sticking. By applying required valve testing procedure valve was easily unstuck. However, airator was immediately removed from service and subsequently returned to apotheus for exam. This is second reported incident of an inspiratory valve sticking. Root cause analysis of this incident revealed that valve sticking problem could be traced directly to imcomplete drying of epoxy compound used to glue together to two halves of airator. Before this incident was reported to apotheus, a second valve sticking incident occurred and was reported on medwatch report 1649397-1997-00001. There were 213 airators mfg with imcomplete drying of epoxy glue. Any of these could potentially have a sticking valve problem. Twenty-eight of these airators were in five hosps and were promptly removed from service. Of remaining 185, 158 were in distributors inventory and 27 were used for apotheus marketing demos & clinical trials. All 213 suspect. These are now being replaced with new airators that have fully dried epoxy glue and also have been carefully tested for unrestricted valve operation. Many of these airators have been stored without pt use in upright position for several months and no valve sticking was detected. Airator is designed to be able to overcome an incident in which oxygen is not flowing to pt through inspiratory relief valve. In this case, negative pressure valve opens allowing pt to breathe room air. However, fact that inspiratory relief valve was sticking shut and impeding pt breathing required submission of this mdr. Health hazard analysis shows that possibility here for present and future pt harm is remote for two reasons. 1) usage instructions for airator require a pre-use check of all airator valves, both inspiratory & expiratory, to verify their operation. It was learned in incident that required valve check was not done, as required. Therefore, to reinforce importance of this preuse check, apotheus will soon install on all airators a highly visible warning sticker. It reads "! Warning! Check valve operation daily. "further, importance of the required pre-use check of all valves will be strongly & personally stressed in follow up training sessions with both pacu nurses & apotheus sales reps. 2) root cause of this malfunction can be traced to incomplete drying of epoxy compound used to glue airator parts together. Incorrect mfg practice has been corrected & there is a changed quality control procedure in place to ensure that it will not be repeated. However, approx 400 have been mfg without uncured epoxy glue & and they work as designed.
Patient Sequence No: 1, Text Type: D, B5