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The biomedical engineer reported that they are having an issue with the arrythmia recall where the it was showing with the incorrect date, march 1970.Arrhythmia recall is historical arrythmia data on the central nurse's station (cns).The customer confirmed that all the real time alarms are reporting correctly.The customer uses arrhythmia recall to print strips, and this is needed when there is an abnormal rhythm so that the doctors and cardiologists can view them.This impacts patient care.Nihon kohden technical support (tech support) informed them that this was a multiple patient receiver (org) issue that was ongoing.No patient harm reported.
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The biomedical engineer reported that they are having an issue with the arrythmia recall where the it was showing with the incorrect date, march 1970.Arrhythmia recall is historical arrythmia data on the central nurse's station (cns).The customer confirmed that all the real time alarms are reporting correctly.The customer uses arrhythmia recall to print strips, and this is needed when there is an abnormal rhythm so that the doctors and cardiologists can view them.This impacts patient care.Nihon kohden technical support (tech support) informed them that this was a multiple patient receiver (org) issue that was ongoing.No patient harm 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.Concomitant medical device: the following device(s) were being used in conjunction with the org, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Multiple patient receiver
model: org-9700a
sn: (b)(4)
approximate age of device: 206 months
device manufacturer date: 12/15/2003
unique identifier (udi) #: na
returned to nihon kohden: not returned
central nurse's station
model: cns-9701a
sn: ni
telemetry transmitters
model: ni
sn: ni.
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Details of the complaint: the biomedical engineer reported that they are having an issue with the arrythmia recall where the it was showing with the incorrect date, (b)(6) 1970.Arrhythmia recall is historical arrythmia data on the central nurse's station (cns).The customer confirmed that all the real time alarms are reporting correctly.The customer uses arrhythmia recall to print strips, and this is needed when there is an abnormal rhythm so that the doctors and cardiologists can view them.This impacts patient care.Nihon kohden technical support (tech support) informed them that this was a multiple patient receiver (org) issue that was ongoing.No patient harm reported.Investigation conclusion: the reported device was not returned for evaluation.Nkc has determined that after 1/1/2021 when the data is transferred from the zm series through the org, the org receiver applies an incorrect date stamp to episodic transmitter data (i.E.A.Arrhythmia recall data, b.St recall data, and c.Nibp measurement data).This date error is either carried over to the cns / rns or blocked so that the episodic data is missing depending on the model of the cns / rns.The root cause of this issue is software deficiency.The following fields are not applicable (na) to the mdr report: d4 lot number & expiration & unique identifier (udi) # g4 device bla number the following fields contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1 on (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 on (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 on (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the org, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Attempt #1 on (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 on (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 on (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Multiple patient receiver model: org-9700a, sn: (b)(6), approximate age of device: 206 months, device manufacturer date: 12/15/2003 , returned to nihon kohden: not returned central nurse's station model: cns-9701a, sn: ni.Telemetry transmitters model: ni, sn: ni.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.
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The biomedical engineer reported that they are having an issue with the arrythmia recall where the it was showing with the incorrect date, (b)(6) 1970.Arrhythmia recall is historical arrythmia data on the central nurse's station (cns).The customer confirmed that all the real time alarms are reporting correctly.The customer uses arrhythmia recall to print strips, and this is needed when there is an abnormal rhythm so that the doctors and cardiologists can view them.This impacts patient care.Nihon kohden technical support (tech support) informed them that this was a multiple patient receiver (org) issue that was ongoing.No patient harm reported.
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