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

Model Number GZ-130PA

Device Problem Output Problem (3005)

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

Event Date 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the telemetry transmitter only reads one ecg lead.The customer has tried different leads, and the issue persisted.There was no error message displayed on the central nurse's station (cns) that was monitoring this unit.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: on 08/24/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: on 08/25/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: on 08/27/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but they did not provide patient information as requested.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the telemetry transmitter.Central nurse's station.Model: cns-6801a.Sn: (b)(4).

Event Description

The biomedical engineer reported that the telemetry transmitter only reads one ecg lead.The customer has tried different leads, and the issue persisted.There was no error message displayed on the central nurse's station (cns) that was monitoring this unit.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported the telemetry transmitter was only reading one ecg lead.They tried different leads, but the issue persisted.No error message was displayed at the central nurse's station (cns).No patient harm was reported.Investigation summary: the customer was provided with an exchange and the reported device was sent in for evaluation.During the device evaluation, nihon kohden repair center (nk rc) was able to confirm a component (cd-334p) malfunctioned, due to an electronic failure.Additionally, there was a rattle noise on the inside of the unit, due to the component issue.Since the customer had already been provided with an exchanged device to resolve the issue, the reported device was dispositioned to be scrapped.Based on the reported information, nihon kohden repair center (nk rc) was able to confirm the reported issue was due to a damaged component, due to an electrical failure.Because of the age of the device, the issue was likely due to damage from wear and tear.There is no evidence to suggest any manufacturing or design issues occurred, based on a review of the trending and historical device history.Trending will continue to be monitored for this device, incident issues, and causes.The following fields contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1.08/24/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2.08/25/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3.08/27/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but did not provide the requested patient information.Additional device information: d10: concomitant medical device: the following device was being used in conjunction with the telemetry transmitter.Central nurse's station: model: cns-6801a.Sn: (b)(6).

Event Description

The biomedical engineer reported the telemetry transmitter was only reading one ecg lead.They tried different leads, but the issue persisted.No error message was displayed at the central nurse's station (cns).No patient harm was reported.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12493563
• MDR Text Key: 272131043
• Report Number: 8030229-2021-01717
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2021
• 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: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• 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-6801A SN (B)(6).; CNS-6801A SN (B)(6).; CNS-6801A SN (B)(4).