MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER

Model Number GZ-130PA

Device Problem Patient Data Problem (3197)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the ecg will show up but then it will intermittently drop out and then come back again on the gz monitor.The bme reported that they tried different lead sets but the issue remains.The bme reported that this is not a patient related issue as they were able to put a different unit on the patient and the issue did not persist.No patient harm was reported.They will be sending the unit into nihon kohden repair center.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: 06/22/2023 emailed the customer via microsoft outlook for the above no information section: no reply was received.Attempt # 2: 06/27/2023 emailed the customer via microsoft outlook for the above no information section: no reply was received.Attempt # 3: 06/30/2023 emailed the customer via microsoft outlook for the above no information section: no reply was received.

Event Description

The biomedical engineer reported that the ecg will show up but then it will intermittently drop out and then come back again on the gz monitor.The bme reported that they tried different lead sets but the issue remains.The bme reported that this is not a patient related issue as they were able to put a different unit on the patient and the issue did not persist.No patient harm was reported.They will be sending the unit into nihon kohden repair center.

Event Description

The biomedical engineer reported that the ecg will show up but then it will intermittenly drop out and then come back again on the gz monitor.The bme reported that they tried different lead sets but the issue remains.The bme reported that this is not a patient related issue as they were able to put a different unit on the patient and the issue did not persist.No patient harm was reported.They will be sending the unit into nihon kohden repair center.

Manufacturer Narrative

Complaint summary: the biomedical engineer reported that the ecg will show up but then it will intermittenly drop out and then come back again on the gz monitor.The bme reported that they tried different lead sets but the issue remains.The bme reported that this is not a patient related issue as they were able to put a different unit on the patient and the issue did not persist.No patient harm was reported.They will be sending the unit into nihon kohden repair center.Investigation summary: nihon kohden repair center (rc) evaluated the unit and could not duplicate the complaint.The device was connected to a cns and simulator, tested for 24 hours, and did not have any signal drops.A definitive root cause could not be determined since nk rc could not duplicate the complaint during evaluation.Possible causes may include loose connections of the lead set cable, use of third-party lead sets not specified for use with the nk device, or network connection issues.Loose cable connections can occur if the cable connector is damaged, or if the cable is not plugged in completely.Damage to cable connectors can occur if inserted or removed with excessive force.The gz operator's manual lists the recommended lead sets to use with the gz transmitter and states that maximum performance of the device cannot be guaranteed with use of third-party accessories not specified for use with the nk device.The gz transmitter uses the customer's wireless network to communicate with the cns.Network connection issues can be due to incorrect network settings, issues with the customer's wireless network, or environmental interference.Review of the complaint device's serial number does not show recurrence or other complaints.Review of the customer's complaint history does not show other similar complaints.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 06/22/2023 emailed the customer via microsoft outlook for the above no information section: no reply was received.Attempt # 2: 06/27/2023 emailed the customer via microsoft outlook for the above no information section: no reply was received.Attempt # 3: 06/30/2023 emailed the customer via microsoft outlook for the above no information section: no reply was received.

• Brand Name: GZ-130PA
• 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: 17243520
• MDR Text Key: 319102085
• Report Number: 8030229-2023-03633
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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
• Device Model Number: GZ-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• 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