MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number	ORG-9100A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of the complaint.The customer reported that when they attempt to view the arrythmia recall (ar) data for the telemetry transmitters, they do not see data or waveforms.They have not had the multiple patient receiver (org) software (sw) updated as of yet.Nihon kohden technical support (ts) let the customer know this is a known issue with the multiple patient receiver (org) and that they need to update the software.Ts informed them of the recall and provided them documentation regarding this and that they can use event list as an alternative to arrhythmia recall in the meantime.The nurses could not view ar feature on the screen or print for the doctor's review for patient diagnosis.Although the device does offer other means to be able to view the data, the customer stated that this impacts patient care for the purpose they are using that data.Real time patient monitoring not affected.The customer updated the software, and the issue was resolved.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 telemetry transmitters 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.Attempt #1 04/08/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient information as requested.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the org.Central nurse's station, model: cns-6201a, sn: (b)(4).
Event or Problem Description
The customer reported that when they attempt to view the arrythmia recall (ar) data for the telemetry transmitters, they do not see data or waveforms.They have not had the multiple patient receiver (org) software (sw) updated as of yet.Nihon kohden technical support (ts) let the customer know this is a known issue with the multiple patient receiver (org) and that they need to update the software.Ts informed them of the recall and provided them documentation regarding this and that they can use event list as an alternative to arrhythmia recall in the meantime.The nurses could not view ar feature on the screen or print for the doctor's review for patient diagnosis.Although the device does offer other means to be able to view the data, the customer stated that this impacts patient care for the purpose they are using that data.Real time patient monitoring not affected.The customer updated the software, and the issue was resolved.No patient harm reported.
Additional Manufacturer Narrative
Details of the complaint the customer reported th:at when they attempt to view the arrythmia recall (ar) data for the telemetry transmitters, they do not see data or waveforms.They have not had the multiple patient receiver (org) software (sw) updated as of yet.Nihon kohden technical support (ts) let the customer know this is a known issue with the multiple patient receiver (org) and that they need to update the software.Ts informed them of the recall and provided them documentation regarding this and that they can use event list as an alternative to arrhythmia recall in the meantime.The nurses could not view ar feature on the screen or print for the doctor's review for patient diagnosis.Although the device does offer other means to be able to view the data, the customer stated that this impacts patient care for the purpose they are using that data.Real time patient monitoring not affected.The customer updated the software, and the issue was resolved.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 transmitted from the zm series through the org, the org receiver applies an incorrect date stamp to episodic transmitter data (i.E., a.Arrhythmia recall screen data, b.St recall screen data, and c.Nibp (non-invasive blood pressure) measurement data).This date error is either carried over to the cns/rns/prefense or blocked so that the episodic data is missing depending on the model of the cns/rns/prefense.As a response to this issue, nk had issued a recall notification on 01/27/2021 on org-9100a, org-9110a, and org-9700a multi-patient receivers, and had announced on 02/02/2021 the release of software version v05-01 on 02/02/2021 for the org-9100, and org-9110 for the us market in order to resolve this issue.The customer had not updated their org software; thus, they are still experiencing the issue.After the customer had updated their org, the issue was resolved.A software update was issued to correct and fix the issue.No additional corrective actions are required at this time.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the org.Central nurse's station; model: cns-6201a; sn: (b)(6).
Event or Problem Description
The customer reported that when they attempt to view the arrythmia recall (ar) data for the telemetry transmitters, they do not see data or waveforms.They have not had the multiple patient receiver (org) software (sw) updated as of yet.Nihon kohden technical support (ts) let the customer know this is a known issue with the multiple patient receiver (org) and that they need to update the software.Ts informed them of the recall and provided them documentation regarding this and that they can use event list as an alternative to arrhythmia recall in the meantime.The nurses could not view ar feature on the screen or print for the doctor's review for patient diagnosis.Although the device does offer other means to be able to view the data, the customer stated that this impacts patient care for the purpose they are using that data.Real time patient monitoring not affected.The customer updated the software, and the issue was resolved.No patient harm reported.

• Brand Name: ORG-9100A
• Common Device Name: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14232578
• Report Number: 8030229-2022-02823
• Device Sequence Number: 14554515
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K071058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1162-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS-6201A SN (B)(6); CNS-6201A SN (B)(6)
• Patient Sex: Unknown