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 revealed tamper seal was intact and battery door was missing.Device passed during functional check.The customer's problem was duplicated during the investigation.Rear/front housing had stained colors and missing battery door.Recommended rear/front housing assembly and battery door to be replaced.Root cause was found to be the customer.Replace both rear/front housing assembly and battery door.
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