The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.However, it was reported the device was not used past its expiry date.This event was reported by a bsc service engineer.The reported healthcare facility is: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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