In addition he noted that the email for approval of changes was missing.The customer was contacted several times for add'l info, and we have not had a response.While it is believed that no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reported per 21cfr part 803.Multiple unsuccessful attempts were made to obtain the device for eval.Multiple unsuccessful attempts were made to obtain the pt outcome.
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