This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).No causes or potential causes of the customers reported problem were found during the review of the service and repair records.A product sample was received for evaluation.Visual inspection showed all labels were intact.During functional check, the customer's reported problem was verified.There was visible bubbling on the downstream occlusion sensor seal.The root cause was normal wear from usage.Replaced contaminated liquid crystal.The downstream occlusion sensor and seal was replaced.
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