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

Model Number GZ-130PA

Device Problems Communication or Transmission Problem (2896); Data Problem (3196); Patient Data Problem (3197); Intermittent Communication Failure (4038)

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

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the gz transmitter experienced frequent and lengthy communication losses at the central nurses station (cns) and failed to retain the patient's data after battery replacement.There were no reports of harm while in patient use.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: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: cns-6801a model #: pu-681ra serial #: (b)(6).Device manufacturer data: 02/06/2020 unique identifier (udi) #:(b)(4).Returned to nihon kohden: na.

Event Description

The customer reported that the gz transmitter experienced frequent and lengthy communication losses at the central nurses station (cns) and failed to retain the patient's data after battery replacement.No reports of patient harm.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitter experienced frequent and lengthy communication losses at the central nurse's station (cns) and failed to retain the patient's data after battery replacement.There were no reports of harm while in patient use.Investigation summary: nihon kohden (nk) received the device on 06/07/2023.Nk repair center (rc) evaluated the device on 09/11/2023.Nk rc connected the unit to a cns, tested it for over 24 hours, and could not duplicate the complaint.Signs of fluid intrusion were also found in the battery compartment.A definitive root cause could not be determined since the complaint could not be duplicated.The fluid intrusion found during the evaluation is likely unrelated to the complaint, as the unit ran normally during the evaluation.Possible causes of the communication loss may be related to the customer's local network environment since the gz transmitter relies on the customer's wireless network to communicate with the cns.Hardware issues with the customer's wireless access points may affect communication.Hardware issues can occur through physical damage or fluid intrusion from user mishandling.Power issues from site outages or surges can affect circuit boards.Or wear-and-tear, which depends on the device's age and frequency of use.Intermittent communication loss can also occur if there is a large distance between the transmitter and access points.Electromagnetic interference from other devices on the customer site may also affect communication.Regarding the issue of loss of patient info after a battery change, a complaint history review from the past two years for cns devices and gz transmitters showed a similar complaint under ticket 152908 in which a patient on a gz transmitter was discharged after the cns showed a communication loss error.It was found that this customer had a history of communication loss issues due to an unstable wireless network and weak wi-fi signal for the affected transmitters.Other complaints regarding loss of patient info after changing batteries could not be found, but because the gz transmitter will momentarily lose communication with the cns while the batteries are being swapped, these issues may be related.A review of the complaint device's serial number shows no other similar complaints.A review of the customer's complaint history shows two (2) similar complaints under tickets 161303 and 161371 for communication loss for gz transmitters.Troubleshooting for both tickets was documented under ticket 161371.Nk network engineer was on site to address these issues and found that the communication loss was likely due to the facility's wireless network.They recommended that the customer move or add more wireless access points.Based on the customer's complaint history, it is possible that the gz transmitter may have had a weak or unstable wireless connection during the battery change, and the unit was only able to send partial data to the cns at the time.The following fields contain no information (ni), as an attempt to obtain information was made, but not provided: attempt # 1: 05/24/2023 emailed the customer for patient information and concomitant medical device: the customer responded with the model and the serial number of the cns.However, they could not provide the patient information.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: cns-6801a model #: pu-681ra serial #: (b)(6) device manufacturer data: 02/06/2020 unique identifier (udi) #: (b)(4).

Event Description

The customer reported that the gz transmitter experienced frequent and lengthy communication losses at the central nurse's station (cns) and failed to retain the patient's data after battery replacement.No reports of patient harm.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17140209
• MDR Text Key: 317588391
• Report Number: 8030229-2023-03607
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• 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: CNS.; CNS.