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.The customer did not return the device for evaluation and will purchase a new device.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
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