The customer reported that eight devices contributed to eight reported events (one device per event).The customer returned one device for evaluation.It could not be determined which reported event was associated with the returned device; therefore, the evaluation of the one returned device will be used for the medwatch.The following mfr's were submitted related to the evaluation: 2183502-2016-01343, 2183502-2016-01342, 2183502-2016-01341, 2183502-2016-01340, 2183502-2016-01339, 2183502-2016-01338, 2183502-2016-01337, and 2183502-2016-01356.One portex® pediatric disposable anesthesia breathing circuit was returned for investigation.The device was received opened and without its original packaging.A review of the device history record found no non-conformities or issues during manufacturing.Visual inspection was performed at a distance of 12" to 24" and under normal conditions of illumination.Examination found no visible tears on the tube and not defects with the returned device.During functional testing, the device was leaked tested; no leaks were observed.An audit was performed on 32 device samples from the product floor inventory.The devices are manufactured with the same process procedures as the reported device.The devices were visually inspected and leak tested.No fault was the device samples during the audit.Investigation was unable to confirm the reported issue and found that the returned device functioned as intended.
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