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

Model Number GZ-130PA

Device Problems Erratic or Intermittent Display (1182); 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 (bme) reported that the gz transmitter was showing fluctuating lead readings whenever there was any movement to the gz transmitter while monitoring a patient, the patient was moved to a different transmitter, no patient harm was reported.The bme reported that the leads were not the issue because they swapped the gz transmitter with a different one using the same leads and they were not able to duplicate the issue.The bme took the gz transmitter out of service and took it to his biomed shop and was able to duplicate the issue using a new set of leads and evaluating it on his simulator.The bme requested to send in the gz transmitter to nihon kohden for repair.The bme said there are no signs of physical damage or fluid intrusion.No patient harm was reported.Nihon kohden technical support provided the bme with a return authorization number to return the device to nka.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.10/31/2023, emailed the biomedical engineer via microsoft outlook for the information above: reply was received from the biomed who stated the device was delivered to nkrc on october 13, 2023, however, he did not provide any of the requested information for the above fields.

Event Description

The biomedical engineer (bme) reported that the gz transmitter was showing fluctuating lead readings whenever there was any movement to the gz transmitter while monitoring a patient, the patient was moved to a different transmitter, no patient harm was reported.The bme reported that the leads were not the issue because they swapped the gz transmitter with a different one using the same leads and they were not able to duplicate the issue.The bme took the gz transmitter out of service and took it to his biomed shop and was able to duplicate the issue using a new set of leads and evaluating it on his simulator.The bme requested to send in the gz transmitter to nihon kohden for repair.The bme said there are no signs of physical damage or fluid intrusion.No patient harm was reported.Nihon kohden technical support provided the bme with a return authorization number to return the device to nka.

Event Description

The biomedical engineer (bme) reported that the gz transmitter was showing fluctuating lead readings whenever there was any movement to the gz transmitter while monitoring a patient, the patient was moved to a different transmitter, no patient harm was reported.The bme reported that the leads were not the issue because they swapped the gz transmitter with a different one using the same leads and they were not able to duplicate the issue.The bme took the gz transmitter out of service and took it to his biomed shop and was able to duplicate the issue using a new set of leads and evaluating it on his simulator.The bme requested to send in the gz transmitter to nihon kohden for repair.The bme said there are no signs of physical damage or fluid intrusion.No patient harm was reported.Nihon kohden technical support provided the bme with a return authorization number to return the device to nka.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz transmitter was showing fluctuating lead readings whenever there was any movement to the gz transmitter while monitoring a patient, the patient was moved to a different transmitter, no patient harm was reported.The bme reported that the leads were not the issue because they swapped the gz transmitter with a different one using the same leads and they were not able to duplicate the issue.The bme took the gz transmitter out of service and took it to his biomed shop and was able to duplicate the issue using a new set of leads and evaluating it on his simulator.The bme requested to send in the gz transmitter to nihon kohden for repair.The bme said there are no signs of physical damage or fluid intrusion.No patient harm was reported.Nihon kohden technical support provided the bme with a return authorization number to return the device to nka.Investigation summary: the reported issue was confirmed and duplicated.During evaluation, repair center was able to confirm there was an issue with the main board due to an electronic malfunction causing the fluctuation of readings from the device.Based on the reported information, we were able to confirm the reported issue was due to a damaged component, due to an electrical failure.This could be caused by physical damage from wear and tear, age of the device or customer mishandling.To resolve the issue, a brand-new exchange unit (gz-130pa, serial number: (b)(6)) was successfully shipped to the customer.Failure of the ecg module and/or its components can occur due to physical damage.Impacts with surfaces or other objects could damage both the exterior enclosure and internals of the device.Internal damage of the device may cause incomplete sending of data or prohibit the device from connecting to the network, the bsm, or the cns.If physical damage is not observed on the device or its components, a module may fail due to normal wear and tear and is dependent on the age of the device and the frequency of its use.Ecg issues caused by module failure are most likely isolated incidents.Historical data reveals no trends of module failure that leads to ecg issues.A serial number review of the reported device (gz-130pa, serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 d10 attempt # 1: 10/24/2023 emailed the biomedical engineer via microsoft outlook for the information above: no reply was received.Attempt # 2: 10/31/2023 emailed the biomedical engineer via microsoft outlook for the information above: reply was received from the biomed who stated the device was delivered to nkrc on (b)(6) 2023, however, he did not provide any of the requested information for the above fields.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 h10 additional manufacturer narrative.

Manufacturer Narrative

**udi related data quality updates only** corrected information: d1 brand name: corrected the brand name from gz-130pa to gz-130p.D2b product code: corrected the product code from drt to mhx.D4 additional device information / model #: corrected the model # from gz-130pa to gz-130p.D4 additional device information / catalog #: corrected the catalog # from gz-130pa to gz-130p.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, per the fda request.

Event Description

The biomedical engineer (bme) reported that the gz transmitter was showing fluctuating lead readings whenever there was any movement to the gz transmitter while monitoring a patient, the patient was moved to a different transmitter, no patient harm was reported.The bme reported that the leads were not the issue because they swapped the gz transmitter with a different one using the same leads and they were not able to duplicate the issue.The bme took the gz transmitter out of service and took it to his biomed shop and was able to duplicate the issue using a new set of leads and evaluating it on his simulator.The bme requested to send in the gz transmitter to nihon kohden for repair.The bme said there are no signs of physical damage or fluid intrusion.No patient harm was reported.Nihon kohden technical support provided the bme with a return authorization number to return the device to nka.

• 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: 18049924
• MDR Text Key: 327207315
• Report Number: 8030229-2023-03846
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: GZ-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 01/09/2024; 01/09/2024
• Supplement Dates FDA Received: 01/11/2024; 08/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• 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; CNS; CNS