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 device was evaluated by service engineer and found to have a cartridge issue.Cartridge replaced.Device under warranty invoice no.(b)(4) dated (b)(6) 2022.
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