The customer reported that the transmitter went offline with no alarm.According to the customer, the central nurse's station (cns) displayed a telemetry not connected message; however, the transmitter itself did not alarm at all.The customer is providing the logs for review.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for device information: no reply was received.
|