There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.No return of device.Customer is purchasing new since this device is discontinued.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
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