Pr (b)(4) follow up emdr for device evaluation.No complaint sample was provided for evaluation.Consequently, the investigation was not able to confirm the reported failure mode.A device history record review for lot 0001085188 was performed.No issues were identified that may have contributed to the reported failure mode.Since no complaint sample was provided for evaluation and the dhr review did not identify any issues that may have contributed to the reported failure mode, a probable root cause could not be identified based on the investigation results.Since no probable root cause was identified based on the complaint investigation, the investigation was not able to identify any corrective or preventive actions for this complaint.This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.
|