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 labels were all in intact; however, the housing was damaged.During functional check, the reported problem was duplicated.There was rear housing assembly damage caused by the customer.The rear housing assembly was replaced.
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