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

Model Number GZ-130PA

Device Problem Application Program Problem (2880)

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

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they tried to use gz monitor (sn (b)(4)), but when they powered it on, the device copied the patient information and waveforms from another gz monitor (sn (b)(4)).They also stated that when this issue happened, the sn (b)(4) bed id got replaced by sn (b)(4) bed id.Sometimes they were able to see waveforms on both gz's and sometimes they just showed on one tele for a while.No harm or injury occurred.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 was used in conjunction with the gz transmitter: gz transmitter: model #: gz-130pa.Serial #: (b)(4).Device manufacturer data: 10/28/2021.Unique identifier (udi) #: (b)(4).

Event Description

The customer reported that they tried to use gz monitor (sn (b)(4)), but when they powered it on, the device copied the patient information and waveforms from another gz monitor (sn (b)(4)).They also stated that when this issue happened, the sn (b)(4) bed id got replaced by sn (b)(4) bed id.Sometimes they were able to see waveforms on both gz's and sometimes they just showed on one tele for a while.No harm or injury occurred.

Manufacturer Narrative

Details of complaint: the customer reported that when powering on a gz transmitter, the device copied the patient information and waveforms from another gz transmitter.The bed id for transmitter sn (b)(6) was replaced by that of transmitter sn (b)(6).The waveforms for both transmitters were sometimes visible, but sometimes only showed on one.No patient harm was reported.Investigation summary: the service history for this facility was reviewed to find similar events.Under ticket 129337, the customer reported another occurrence of the same issue.The proposed resolution was to reboot the server.On (b)(6) 2022, the customer stated they were looking for the right time frame to perform the server reboot to minimize down time in patient monitoring.On (b)(6) 2022, the customer called back to report the same issue.Under ticket 150060, the customer reported the issue continue to occur sporadically.On (b)(6) 2022, the issue was reportedly resolved by adding an additional ip address to the telemetry server configuration tool.No other reports of duplicate patient information were found.The configuration of the telemetry system caused the reported issue.Configurations are verified for performance at system design and install.When there is an addition or removal of devices from the network, the configuration file would need the corresponding update.There was no evidence of an nk device malfunction, and no recurrence of the issue since the correction was implemented.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 when powering on a gz transmitter, the device copied the patient information and waveforms from another gz transmitter.The bed id for transmitter sn (b)(6) was replaced by that of transmitter sn 00589.The waveforms for both transmitters were sometimes visible, but sometimes only showed on one.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: 13780152
• MDR Text Key: 289024020
• Report Number: 8030229-2022-02620
• 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: 04/13/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/16/2022
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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: GZ TRANSMITTER; GZ TRANSMITTER