One portex® custom single limb circuit was returned for investigation.The device was received inside a plastic bag with its original closed packaging.The customer reported that two devices contributed to two reported events (one device per event).The customer returned one device for evaluation.It could not be determined which reported occurrence that device was associated with; therefore, the evaluation of the device will be used for the medwatch.The following mfr were submitted related to the evaluation: 2183502-2016-01676 and 2183502-2016-01677.Visual inspection found no deformations/holes along the tube and the device was correctly assembled; no defects were observed.Additionally, no holes were found on the breathing bag.During functional testing, the returned tube and bag were connected to the leak testing device; no leaks were detected.The returned device then underwent a retention and bond strength test using a calibrated weight and brackets.During the strength and bond test, no separation on the parts or on the bonding was observed.After the strength and bond test, the tube and bag were reconnected to the leak testing device; no leaks were observed.Investigation was unable to find fault with the returned device and found that the device operated as intended.(b)(4).
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