MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; TRANSMITTER

Device Problems No Device Output (1435); Communication or Transmission Problem (2896); Output Problem (3005)

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

Event Date 08/09/2023

Event Type  malfunction  

Event Description

The biomedical engineer reported that the gz telemetry transmitters (teles) will be working fine then randomly fall of the central nurse's station (cns).The admitted patient also disappears from the gz.This device noted in the ticket is a place holder device.Qa contacted the biomedical engineer (bme)) and the nurse manager for device information and details, but they have been unresponsive.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer reported that the gz telemetry transmitters (teles) will be working fine then randomly fall of the central nurse's station (cns).The admitted patient also disappears from the gz.This device noted in the ticket is a place holder device.Qa contacted (b)(6) (biomedical engineer (bme)) and (b)(6) (nurse manager) for device information and details, but they have been unresponsive.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.Attempt #1 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station model: ni.Sn: ni.

Event Description

The biomedical engineer (bme) reported that the gz transmitters would randomly drop monitoring at the central nurse's station (cns) during patient monitoring.The admitted patient would also disappear from the gz transmitter.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz transmitters would randomly drop monitoring at the central nurse's station (cns) during patient monitoring.The admitted patient would also disappear from the gz transmitter.No patient harm was reported.Investigation summary: to address the issue of the gz transmitter falling off of the cns, nihon kohden (nk) on-site support was sent to resolve the issue.The nk personnel stated they were able to resolve the issue and the cause of the issue was that the customer was not performing the correct procedure when using hi-q view.Hi-q view is used to allow monitoring of a gz device on a bedside monitor.There is no evidence of an nk device malfunction that may have contributed to the reported issue.The root cause of the gz falling off the cns is likely related to user education which was resolved with an on-site visit.A review of the reported device type does not reveal additional related complaints.A complaint history review of the customer's account does not reveal similar complaints.Central nurse's station: model: ni.Sn: ni.

• 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: 17706331
• MDR Text Key: 323222653
• Report Number: 8030229-2023-03766
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• 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
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION
• Patient Race: Asian