[67330]
During the required pre-use inspection of six aircare airators by an apotheus employee prior to their use in a hosp test of the aircare source control sys, it was discovered that the inspiratory relief valve was sticking on each of these airators. In addition, on two of these six airators, the negative pressure relief valve was also sticking. By conducting the prescribed valve checking procedure, the inspiratory relief valve on two of the airators was unstuck. However, this procedure was not successful on four of the airators. All six airators were taken out of service immediately. The four airators with the valves stuck were returned at once to apotheus for analysis. These six airators had been used two months previously in this hosp and they worked perfectly. In the intervening two month period, they were stored in a closet under unk conditions. This is the first and only known incidence of this situation. There were no pt's involved. Root cause analysis of this incident revealed that the valve sticking problem can be traced directly to incomplete drying of the epoxy compound used to glue together the two halves of the airator. There were 213 airators that were mfg this way and could potentially have a sticking valve problem. Twenty-eight of these airators were in five hospital's and were promptly removed from service. Of the remaining 185, 158 were in distributors inventory and 27 were used for apotheus marketing demonstrations and clinical trials. All 213 suspect airators are being recalled to apotheus and replaced with new airators. The airator is designed to be able to overcome an incident in which the inspiratory relief valve may not be operative. This will normally occur because oxygen is not flowing. In this case, the negative pressure valve opens and allows the pt to breathe room air. However, the fact that both the inspiratory relief valve and the negative pressure relief valve were both stuck shut simultaneously required the submission of this mdr. The health hazard analysis, attached to this report, shows that the possibility here for present and future pt harm is remote for two reasons. 1) the usage instructions for the airator require a pre-use check of all six airator valves, both inspiratory and expiratory, to verify their operation. It was just such an inspection that discovered this problem. 2) the root cause of this malfunction can be traced to the incomplete drying of the epoxy compound used to glue the airator parts together. This incorrect mfg practice has been corrected and there is a changed quality control procedure in place to ensure that it will not be repeated.
Patient Sequence No: 1, Text Type: D, B5