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

Model Number GZ-130PA

Device Problem Pacing Problem (1439)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the gz transmitter doesn't see patient pacing in time.The customer stated that several units will not display patient pacing marks with the patient.The issue affects several gz units.The pace marks are showing on the ecg machine.Technical support (ts) is working with the customer to resolve the problem.There was no patient injury 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.Additional model information: concomitant medical device: the following device was used in conjunction with the gz transmitter: ecg machine: model #: ni; serial #: ni; device manufacturer data: ni; unique identifier (udi) #: ni; returned to nihon kohden: ni.

Event Description

The customer reported that the gz transmitter doesn't see patient pacing in time.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitter was not seeing patient pacing in real time.However, the pacer marks were showing on the ecg machine.No harm or injury was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Based on the operator's manual for the gz-130pa transmitter, there are several causes of pacing spikes not being detected.Pacing pulses might not be detected if the pacing pulse on the body surface is too small.The monitor might detect the pulse as a qrs.This may also be caused by incorrect positioning of the electrodes on the patient.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.This customer does not have any additional related complaints for this device.Causes may be related to patient condition and patient prep.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 10/15/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/19/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 10/25/2021 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have any of this information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: ecg machine: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.

Event Description

The customer reported that the gz transmitter was not seeing patient pacing in real time.There was no patient injury 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: 12716238
• MDR Text Key: 279105290
• Report Number: 8030229-2021-01876
• 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: 09/26/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2017
• 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: ECG MACHINE.; ECG MACHINE.