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

Model Number	ORG-9100A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that there are 4 telemetry transmitters in communication loss with the central nurse's station (cns).The customer later stated that the patients on multiple patient receiver (org) sn (b)(4) was moved to another org, and they came out of communication loss and able to monitor patients on them.The other org sn (b)(4) was rebooted and came out of communication loss.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that there are 4 telemetry transmitters in communication loss with the central nurse's station (cns).The customer later stated that the patients on multiple patient receiver (org) sn (b)(4) was moved to another org, and they came out of communication loss and able to monitor patients on them.The other org sn (b)(4) was rebooted and came out of communication loss.No patient harm was 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.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided.Attempt #1 06/16/2022 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.Multiple patient receiver model: org-9100a.Sn: (b)(4).Device manufacturer date: 08/29/2012.Unique identifier (udi) #: (b)(4).Central nurse's station model: cns-6801a.Sn: (b)(4).Device manufacturer date: 03/04/2021.Unique identifier (udi) #: (b)(4).
Event or Problem Description
The biomedical engineer (bme) reported that there are 4 telemetry transmitters in communication loss with the central nurse's station (cns).The customer later stated that the patients on multiple patient receiver (org) sn (b)(6) was moved to another org, and they came out of communication loss and able to monitor patients on them.The other org sn (b)(6) was rebooted and came out of communication loss.No patient harm was reported.
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bme) reported that there are 4 telemetry transmitters in communication loss with the central nurse's station (cns).The customer later stated that the patients on multiple patient receiver (org) sn (b)(6) was moved to another org, and they came out of communication loss and able to monitor patients on them.The other org sn (b)(6) was rebooted and came out of communication loss.No patient harm was reported.Investigation conclusion: the issue of communication loss was resolved by rebooting the orgs that were receiving signals from the affected transmitters.As the devices were not returned for evaluation, root cause cannot be determined.As the orgs were able to come out of comm loss after being rebooted, it is unlikely that the comm loss occurred as a result of a device defect.Complaint history review of pu-681ra serial number (b)(6) do not reveal any additional complaint relating to communication loss.This event is likely an isolated incident.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the org.Multiple patient receiver model: org-9100a sn: (b)(6) device manufacturer date: 08/29/2012 unique identifier (udi) #: (b)(4).Central nurse's station model: cns-6801a sn: (b)(6) device manufacturer date: 03/04/2021 unique identifier (udi) #: (b)(4).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.

• 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: 15006336
• Report Number: 8030229-2022-02952
• Device Sequence Number: 12450961
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 06/13/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2010
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS-6801A SN (B)(6); CNS-6801A SN (B)(6); ORG-9100A SN (B)(6); ORG-9100A SN (B)(6)
• Patient Sex: Unknown