The customer reported that the patient name disappeared from the screen of the transmitter device (zm-530pa), but waveforms remained intact.No consequence or impact to the patient was reported.The customer indicated that they will not be providing any additional information regarding the event.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: serial number, approximate age of device.No serial number was provided, so the age of the device is unknown, device manufacturer date.
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Details of the complaint: on (b)(6) 2019, customer at (b)(6) reported the following issue: name vanished but waves remained.This was provided to nka technical support (ts) from the hospital's department logs.The incident occurred on (b)(6) 2019 in room/box 526 for the cns-6801a (pu-681ra sn: ni).No further information will be provided from the hospital.Service requested: none.Service performed: none.Investigation result: there was a reported incident in which the "name vanished but waves remained".The details surrounding the incident were not provided and information on the extent of any troubleshooting is unknown.Review of tickets opened at (b)(6) found one issue reported relating to disappearing name: 65897 reported 08/15/19 in which a patient name on a cns was reported to disappear while waveforms were still present.The incident description appears similar to the issue described in the current issue however no conclusion can be made with the available information.Further investigation of the issue is limited as the device logs were not retrieved for evaluation, nor was the device serial number provided.Investigation conclusion: based on the information provided, it is not possible to make any determination of the root cause.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: serial number, approximate age of device.No serial number was provided, so the age of the device is unknown, device manufacturer date.Additional information: date of this report, date user facility/importer became aware of the event, type of report, date report sent to fda, date report sent to manufacturer, date received by manufacturer, type of report, if follow-up, what type?, device evaluated by manufacturer, event problem and evaluation codes.
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