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

Model Number GZ-130PA

Device Problems Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

The customer reported the gz transmitter lost power while monitoring a patient.

Manufacturer Narrative

The customer reported the gz transmitter lost power while monitoring a patient.They tried new batteries, but the device would not power back up.They swapped in another transmitter to continue monitoring the patient.The customer has requested 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.Concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: ni, serial #: ni.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitter lost power while monitoring a patient.They tried new batteries, but the device would not power back up.They swapped in another transmitter to continue monitoring the patient.The customer sent the device in for evaluation.No harm or injury was reported.Investigation summary: during the evaluation of the returned device nihon kohden repair center (nk rc) was able to confirm the reported issue of the device not powering on.Nk rc observed fluid intrusion and contamination of the device's internal components.Fluid intrusion can cause damage to electronics due to several reasons.1.Short circuits: when fluid, especially water, enters electronic devices, it can create short circuits.Water is conductive, and when it comes into contact with the electrical components inside the device, it can create unintended paths for electric current.This can lead to the malfunctioning or complete failure of the affected components.2.Corrosion: fluids can contain corrosive substances or impurities that can corrode the metal components and solder joints on circuit boards.Corrosion can degrade the conductivity of electrical pathways, causing poor connections or complete disconnection.Over time, corrosion can eat away at the metal traces and components, rendering the device inoperable.3.Damage to sensitive components: electronic devices often contain sensitive components like integrated circuits, transistors, capacitors, and resistors.These components are designed to operate within specific voltage, current, and temperature ranges.When fluid infiltrates these components, it can disrupt their delicate structures and alter their properties, leading to a loss of functionality or permanent damage.4.Oxidation: certain fluids, especially water or water-based solutions, can promote oxidation when they come into contact with metal surfaces.Oxidation occurs when oxygen reacts with the metal, causing it to deteriorate over time.This can weaken the electrical connections and eventually cause failure of the affected components.5.Contamination: fluid intrusion can introduce contaminants, such as dirt, dust, minerals, or chemicals, into electronic devices.These contaminants can interfere with the proper functioning of electrical contacts, switches, and other moving parts.They can also create unwanted electrical pathways or cause physical blockages, leading to malfunctions or operational errors.The root cause likely related to mishandling.There is no recurrence history for this device.Attempt # 1: 10/10/2022 emailed the customer for all information in the ni list above: no reply was received.Attempt # 2: 10/18/2022 emailed the customer for all information in the ni list above: no reply was received.Attempt # 3: 11/02/2022 emailed the customer for all information in the ni list above: no reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: ni; serial #: ni.

Event Description

The customer reported that the gz transmitter lost power while monitoring a patient.No patient harm 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: 15757106
• MDR Text Key: 307809306
• Report Number: 8030229-2022-03190
• 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: 08/02/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2017
• 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: CNS.; CNS.