MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120P; TRANSMITTER

Model Number	GZ-120P
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer reported that the gz transmitter was producing a large amount of artifact for the ecg intermittently and has happened multiple times on multiple patients and multiple lead sets have been tried.No patient harm occurred.The biomedical engineer requested a warranty exchange and returned this unit to nihon kohden.
Additional Manufacturer Narrative
Complaint details: the biomedical engineer reported that the gz transmitter was producing a large amount of artifact for the ecg intermittently and has happened multiple times on multiple patients and multiple lead sets have been tried.No patient harm occurred.The biomedical engineer requested a warranty exchange and returned this unit to nihon kohden.A review of the serial number 1021 for this gz-120pa for previous reports of this type from the customer and no other reports of "intermittent ecg artifact" has been received to nihon kohden.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.
Additional Manufacturer Narrative
Complaint details: the biomedical engineer reported that the gz transmitter was producing a large amount of artifact for the ecg intermittently and has happened multiple times on multiple patients and multiple lead sets have been tried.No patient harm occurred.The biomedical engineer requested a warranty exchange and returned this unit to nihon kohden.A review of the serial number (b)(6) for this gz-120pa for previous reports of this type from the customer and no other reports of "intermittent ecg artifact" has been received to nihon kohden.Investigation summary: nihon kohden repair center (nkrc) inspected the device and found signs of fluid intrusion in the ecg port and along the inner walls of the device.Upon testing the device and moving it around to test signal range there was intermittent signal loss.Additionally, the battery port showed signs of corrosion on them.Based on the physical condition of the unit, the most probable root cause was due to customer mishandling/abuse.To resolve the issue, an exchange unit (gz-120pa, serial number: (b)(6)) was shipped successfully to the customer.We have identified other known ecg issues which are listed below for reference: fuzzy or inaccurate waveforms (e.G., sawtooth patterns, square waves) and wave artifacts (signal noise, lead placement, lead connection, network interference) may be caused by faulty lead placement or faulty leads, or may require the ecg system relearning the patient's rhythm.Lead sets are used to acquire ecg readings, and the users should verify that the leads are authorized for use with the transmitter in operation before monitoring a patient.Improper connection of leads (leads not properly seated), and/or damaged or contaminated leads (dirt, dust and/or cleaning residues) may contribute to ecg issues.If the leads are not seated properly to the transmitter, readings will not appear properly.Users should ensure that all cable connections are secure before monitoring a patient.Damage to lead sets are most likely a result of mishandling that results in the damage to the inner wires of the leads.Damage to the conductive wires would prevent data from reaching the transmitter and transferring over to the bsm or cns.Buildup of residues on contact points could interfere with the stable flow of data or create a weak signal that may appear as a flat line or as broken waveforms on the transmitter, bsm, or cns.Lead issues resulting in the above-mentioned failure modes would be immediately recognizable by the user and addressed promptly.Attempt # 1: 10/24/2023 emailed the customer via microsoft outlook for patient information: reply was received from the biomedical engineer who reported that "the device was sent in on october 16, 2023, and i do not have the patient information you requested.".
Event or Problem Description
The biomedical engineer reported that the gz transmitter was producing a large amount of artifact for the ecg intermittently and has happened multiple times on multiple patients and multiple lead sets have been tried.No patient harm occurred.The biomedical engineer requested a warranty exchange and returned this unit to nihon kohden.
Additional Manufacturer Narrative
**udi related data quality updates** corrected information: d1 brand name: corrected the brand name from gz-120pa to gz-120p.D2b product code: corrected the product code from drt to mhx.D4 additional device information / model #: corrected the model # from gz-120pa to gz-120p.D4 additional device information / catalog #: corrected the catalog # from gz-120pa to gz-120p.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.Additional information: b4 data of this report g6 type of report h2 if follow up, what type?.
Event or Problem Description
The biomedical engineer reported that the gz transmitter was producing a large amount of artifact for the ecg intermittently and has happened multiple times on multiple patients and multiple lead sets have been tried.No patient harm occurred.The biomedical engineer requested a warranty exchange and returned this unit to nihon kohden.

• Brand Name: GZ-120P
• Common Device Name: 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: 18062471
• Report Number: 8030229-2023-03847
• Device Sequence Number: 8041539
• Product Code: MHX
• UDI-Device Identifier: 04931921117392
• UDI-Public: (01)04931921117392(21)1021
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2024
• 2 Devices were Involved in the Event: 1 2

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: GZ-120P
• Device Catalogue Number: GZ-120P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/16/2024; 01/16/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 01/17/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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
• Patient Sex: Unknown