The event occurred in (b)(6) with the valve which is sold bulk, non-sterile to the customer for further processing into final sterile packs.A similar device is distributed by quest medical in us, hence this medwatch is being submitted.The complaint sample will be evaluated and a follow up medwatch will be submitted if additional information becomes available.
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The device was evaluated and was found to have functioned as intended.The device is intended to relieve pressure at negative pressure of -150mmhg and positive pressure build up of +340mmhg (avg).During simulated use testing conducted on the complaint sample, leaking was observed from the pressure relief valve under the hood at approximately 242.1mmhg which is within the acceptable range.To determine if the static pressure (the head height between the patient and the valve) caused the valve to leak, the valve was connected to a water inlet at head height of about 4 ft.(89mmhg).No leak was observed through the device.The valve was later subjected to lower pressure of about 12 inches of water (22.4mmhg), no leak was observed.A dhr review was conducted and no anomalies related to the complaint condition were found.
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