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

Model Number GZ-120PA

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

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

Event Date 10/10/2023

Event Type  malfunction  

Event 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.

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.

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 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-120PA
• 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: 18062471
• MDR Text Key: 327272867
• Report Number: 8030229-2023-03847
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• 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: 01/17/2024

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
• Device Model Number: GZ-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2019
• 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