Complaint details: the customer reported on (b)(6) 2019 that their unit does not give a clear waveform.They have tested the system with several sets of leads.Service requested: customer wanted an exchange for the defective unit.Service provided: physical evaluation: missing battery cover assembly but no sign of fluid intrusion or physical damage.Verify the complaint: could not duplicate the complaint.Transmitter does send a clear waveform.Investigation result: the zm-541pa; sn:(b)(4) was placed into service on 03/15/19, which is less than a week at the time of the reported issue.The unit was returned, and evaluation could not duplicate the reported issue.A review of device history found no previously reported issue with the unit or nka servicing.Similar complaints using "zm-541pa distorted heart rate" gave no results.Based on the device service history and similar search query, adverse trend is not suspected with this device.The issue could not be duplicated by the repair center.The customer was sent an exchange unit on (b)(6) 2019 and no further issue was reported with the exchanged device.The root cause of the issue was determined to be user error.Review of the device history record (dhr) shows that the unit has no history of capa, ncmr, refurbishing, or other suspected defects.Correctred information: f9.Approximate age of device: incorrectly calculated.H4.Manufacturer date incorrectly listed on mdr initial.Additional information: b4.Date of this report, d11.Concomitant medical products, f6.Date user facility/importer became aware of the event, f7.Type of report, f11.Date report sent to fda, f13.Date report sent to manufacturer, g4.Date received by manufacturer, g7.Type of report, h2.If follow-up, what type? additional information, correction, device evaluation, h3.Device evaluated by manufacturer?, h6.Event problem and evaluation codes, h10.Additional manufacturer narrative.D11.Concomitant medical products: central nurses station (cns) was monitoring the transmitter at the time of the transmitter issue.No model/serial was obtained for the cns.
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