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

Model Number GZ-130PA

Device Problems Overheating of Device (1437); Battery Problem (2885)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their transmitter keeps overheating and has a short battery life.The customer clarified that the unit would gets hot enough for it to cause slight discomfort for the patient that is connected to it via leads.No harm or injury actually occurred.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 their transmitter keeps overheating and has a short battery life.The customer clarified that the unit would gets hot enough for it to cause slight discomfort for the patient that is connected to it via leads.No harm or injury actually occurred.They will be sending this unit in for an exchange.

Event Description

The customer reported that the transmitter kept overheating and had a short battery life.The unit would get hot enough to be slightly uncomfortable for the patient.No harm or injury occurred.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter kept overheating and had a short battery life.The unit would get hot enough to be slightly uncomfortable for the patient.No harm or injury was reported.Investigation summary: on 2/12/2022 the customer reported that the gz was overheating and had a short battery life.The unit would get hot enough to be uncomfortable for the patient, but no patient harm was reported.The phenomena of the device overheating, warm to the touch, or hot to the touch, are caused by incorrectly inserting the batteries, forcibly inserting the batteries, or device damage.The actions taken in the design 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: · showing a figure of how to insert the batteries based on the event details, it is unlikely that user inserted the batteries incorrectly, i.E., with the wrong polarity.It is presumed there was damage or a deformation of the battery terminal that led to the reported overheating and short battery life.This device was installed on (b)(6) 2020 with no prior history of overheating and no recurrence history of the reported issue.The following fields contain no information (ni), as an attempt to obtain information was made, but not provided: a2 - a6 b6 b7 d10 attempt #1 03/15/2022 emailed the customer via microsoft outlook for all items under the no information section.They replied that the requested information was not available.Additional information: b4 date of this report d9 device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• 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: 13780159
• MDR Text Key: 287267796
• Report Number: 8030229-2022-02619
• 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
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2018
• 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