The customer reported that the org is dropping its signal on 4 transmitters that are attached to it.No consequence or impact to the patients were reported.During troubleshooting with nihon kohden tech support, it was discovered that the antenna for this org setting was set to antenna -1 instead of diversity.This caused the org to only pick up signal from the a side.Had the user corrected the setting to diversity and the signal restored.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.The following devices were being used in conjunction with the org: antenna, pu-681ra, (sn: (b)(4)); zm-531pa, (sn: (b)(4)); zm-531pa, (sn: (b)(4)); zm-531pa, (sn: (b)(4)); zm-531pa, (sn: (b)(4)).
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Details of complaint: on (b)(6) 2019, customer reported they were experiencing intermittent signal loss issues and dropouts for their wireless telemetry devices on the 3rd floor at 3 south.Customer was unaware of any construction or power outage that occurred that day.During the troubleshooting session with nk tech support, it was discovered that the org device's antenna setting was set to "-1" instead of "diversity".The setting caused org device to only receive signals from the a side.Once the settings were changed to diversity, the issue was resolved.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: this org device was put into service on 4/15/2018.Service history shows this is the first time the reception issue was reported.This information suggests that between 4/15/2018 and 6/19/2019, settings or telemetry system may have been changed or reconfigured.There is no further information.The root cause could not be determined.D11.Concomitant medical products: the following devices were being used in conjunction with the org: antenna: pu-681ra (sn: (b)(6).Zm-531pa (sn: (b)(6).Zm-531pa (sn: (b)(6).Zm-531pa (sn: (b)(6).Zm-531pa (sn: (b)(6).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.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.
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