The biomedical engineer (bme) reported that the transmitter gave irregular ecg readings.After researching the error code "low mv," nk ts found that it has to do with lead placement or defective leads or electrodes.The leads on the simulator may not be functioning correctly.The customer was advised to try changing them out, using proper lead placement to try and resolve the issue.Nk has not yet heard back regarding the results of the suggested troubleshooting tips.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.Additional device information: concomitant medical products: the following device was being used in conjunction with the transmitter: cns: no model or s/n was provided.
|
Details of complaint: the biomedical engineer (bme) reported that the transmitter gave irregular ecg readings.After researching the error code "low mv," nk ts found that it had to do with lead placement or defective leads or electrodes.The leads on the simulator may not be functioning correctly.The customer was advised to try changing them out, using proper lead placement to try and resolve the issue.No patient harm or injury was reported.Investigation summary: the customer had used new leads and electrodes as well as redoing patient preparation, but the issue persisted.They replaced the complaint device with another transmitter and there were no issues with the new transmitter, suggesting that it is not likely a patient related issue or an environmental issue.The customer used a simulator on the transmitter and was getting a low mv error.The customer indicated that they have previously observed this low mv issue on a zm device that had fluid intrusion.The complaint device was not returned to be evaluated.The complaint device had been in service since 03/28/2008.A review of the history of the serial number identified no other issues reported on the device.Based on the available information, a definitive root cause could not be identified.Possible causes of the issue are physical damage on the device, fluid intrusion, and wear and tear of the components of the device.
|