This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for mobility issue since the sample was not returned for evaluation.Based on the information given, the exact root cause of the event cannot be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
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