The customer reported that this unit will not show the heart rate (hr).The customer tested the unit on a simulator with known good leads and the transmitter does not show the hr.The customer will send in the unit to be exchanged.There was no patient injury reported.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: a2 - a6.Attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/10/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 01/15/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/10/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 01/15/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/10/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 01/15/2024 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: 12/29/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 01/10/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 01/15/2024 emailed the customer via microsoft outlook for device information: no reply was received.
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