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

Model Number GZ-130PA

Device Problem Battery Problem (2885)

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

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this transmitter is warm to touch.No harm or injury occurred.The nurse that found the device, removed the batteries, and put new batteries in, but the issue occurred again.They will be sending this unit in for an exchange.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.

Event Description

The customer reported that this transmitter is warm to touch.No harm or injury occurred.The nurse that found the device, removed the batteries, and put new batteries in, but the issue occurred again.They will be sending this unit in for an exchange.

Event Description

The customer reported that the transmitter was warm to touch.They replaced the batteries with new ones, but the issue persisted.No harm or injury occurred.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter was warm to touch.They replaced the batteries with new ones, but the issue persisted.No harm or injury was reported.Investigation summary: the phenomena of device overheating, warm to touch, hot, are caused by incorrectly inserting the batteries or forcibly inserting the batteries.The actions taken in designs are: device is equipped with a torsion spring to minimize terminal damage / deformation.Device is equipped with over current protection in case battery is inserted incorrectly.Design of the battery compartment in which the battery cannot be inserted in the opposite polarity.Attached a sign that indicates the direction of batteries the actions taken in labelling include: shows a figure of how to insert the batteries.There is insufficient information available to determine the cause of the reported event.Overheating is presumed to be caused by damage or deformation of the battery terminals.This device was installed on 10/24/2018 with no history of overheating.There is no recurrence history for this device.The following fields contain no information (ni), as an attempt to obtain the information was made, but not provided: attempt #1 04/07/2022 emailed customer via microsoft outlook for all items under the no information section.The customer replied, stating all requested information was unknown.

• 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: 14054215
• MDR Text Key: 289358669
• Report Number: 8030229-2022-02731
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2017
• 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: NI.; NI.