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

Model Number GZ-130PA

Device Problems Overheating of Device (1437); Temperature Problem (3022)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

The customer reported that this gz monitor recently got very hot.This issue did not occur during patient use but while it was being tested prior to being connected to a patient.No harm or injury was reported.

Manufacturer Narrative

The customer reported that this gz monitor recently got very hot.This issue did not occur during patient use but while it was being tested prior to being connected to a patient.No harm or injury 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.

Manufacturer Narrative

Details of complaint: the customer reported that this gz transmitter got very hot.This issue did not occur during patient use but while the unit was being tested prior to being connected to a patient.No harm or injury was reported.Investigation summary: on (b)(6)2022, the customer reported that the gz device got very hot during use.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 the reported device was sent to nka under a later ticket 135730.The reported issue could not be duplicated.The service history for this gz device shows this is an isolated incident, with no recurrence history.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.

Event Description

The customer reported that this gz transmitter got very hot.This issue did not occur during patient use but while the unit was being tested prior to being connected to a patient.No harm or injury 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: 13654504
• MDR Text Key: 288833587
• Report Number: 8030229-2022-02554
• 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: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• 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: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• 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