MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; TRANSMITTER

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the gz telemetry transmitter disconnected by itself.This happened on 10/09/2023, but they reported this on 11/13/2023.They do not know if there was any error showing on the central nurse's station (cns) or if the cns tile went into communication loss.They would like to have logs reviewed to see what happened.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.Central nurse's station: model: cns-6801a.Sn: (b)(6).Device manufacturer date: 07/01/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.

Event Description

The biomedical engineer reported that the gz telemetry transmitter disconnected by itself.This happened on 10/09/2023, but they reported this on 11/13/2023.They do not know if there was any error showing on the central nurse's station (cns) or if the cns tile went into communication loss.They would like to have logs reviewed to see what happened.No patient harm was reported.

Event Description

The biomedical engineer reported that the gz telemetry transmitter discharged from the central nurse's station on its own.They did not know if an error message displayed when this happened.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that the gz telemetry transmitter discharged from the central nurse's station on its own.They did not know if an error message displayed when this happened.This occurred on 10/09/2023, but it was not reported by the customer until 11/13/2023.No patient harm was reported.Investigation summary: they wanted to have logs reviewed to see what happened.The customer provided the cns and g9 monitor logs which were reviewed by nihon kohden corporate (nkc).The g9 monitor logs showed there was a disconnect while in hi-q view between the g9 monitor and the gz transmitter, however a specific root cause from the cns and g9 monitor logs could not be identified.Multiple requests for the gz transmitter logs were sent to the customer but the customer was unresponsive.Possible causes may include moving the gz transmitter out of the wireless network range, depletion of the battery charge, or issues with the wireless network.The gz transmitter relies on a wireless network connection to communicate with the patient monitoring network.This can be affected by the status the access points are in, network hardware settings, or environmental interference.If the issue recurs, nkc will re-investigate the issue.Nk will continue to monitor and trend similar complaints.The following fields contains no information (ni), as attempts to the obtain information were made, but not provided: d1 brand name.D4 model number.Catalog number.Serial number.Udi number.G4 pma / 510k number.H4 device manufacture date.Attempt #1 11/22/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 11/27/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 11/28/2023 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 devices were used in conjunction with the gz transmitter: g9 monitor: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: not returned central nurse's station: model: cns-6801a.Sn: (b)(6).Device manufacturer date: 07/01/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.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.H11 additional manufacturer narrative.

• Brand Name: NI
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18315718
• MDR Text Key: 330355036
• Report Number: 8030229-2023-03941
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CNS-6801A SN (B)(6).; CNS-6801A, SN: (B)(6).