The biomedical engineer (bme) reported that the transmitter was experiencing sporadic ecg waveform output.The unit would also read the heart rate (hr) low, then spike high and alarm asystole.The bme tested the transmitter on a simulator and received the same results.There was no physical damage or fluid intrusion.No patient harm was 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 field contains no information (ni), as attempts to obtain the information were made, but not provided: additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: cns: model #: ni, serial (b)(6), device manufacturer data: ni, unique identifier (b)(4), returned to nihon kohden: na.Org: model #: org-9110a, serial (b)(6), device manufacturer data: 25/02/2021, unique identifier (b)(4), returned to nihon kohden: na.
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