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

Model Number GZ-130PA

Device Problems Premature Discharge of Battery (1057); Overheating of Device (1437); Battery Problem (2885)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

The customer reported that this gz monitor is getting too warm to touch.No harm or injury occurred.The customer also reported that they believe that this is causing a shorter gz battery life.

Manufacturer Narrative

The customer reported that this gz monitor is getting too warm to touch.No harm or injury occurred.The customer also reported that they believe that this is causing a shorter gz battery life.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 device information: concomitant medical device: the following device(s) were used in conjunction with the gz transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.3 rns's: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitter was getting too warm to the touch.They also reported they believe this was causing a shorter battery life for the device.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.Based on the available information, the cause of the reported event cannot be determined.Heat and low battery life is presumed to occur from damaged or deformed battery terminals.This device was installed on 07/09/2021 with no history of overheating or short battery life.There is no recurrence history for this device.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2.A4.B6.B7.D10.Attempt #1: 04/26/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 04/28/2022 emailed customer via microsoft outlook for all items under the no information section.The customer replied that the requested information was unknown.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the gz transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.3 rnss: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

Event Description

The customer reported that the gz transmitter was getting too warm to the touch.No harm or injury occurred.

• 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: 14251196
• MDR Text Key: 290810970
• Report Number: 8030229-2022-02779
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: 05/14/2021
• 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
• Treatment: 3 REMOTE NURSES STATION'S (RNS'S); 3 REMOTE NURSES STATIONS (RNSS); CENTRAL NURSES STATION (CNS); CENTRAL NURSES STATION (CNS)
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White