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

Model Number GZ-130PA

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer stated that the gz-130pa transmitter experienced an issue which caused both the war-room central nursing station (cns) and the nursing floor registered nursing station (rns) to show 'communication loss," resulting in the patient waveform to not be watched.Details of complaint: nihon kohden telemetry transmitter gz130pa experienced an issue which caused both the war-room central nursing station (cns) and the nursing floor registered nursing station (rns) to show 'communication loss", resulting in the patient waveform to not be watched.This problem has been experienced several times when trying to begin use of a telemetry box, but this is the 2nd time a working box on a patient suddenly experienced the issue and dropped out.We have been working with the vendor nihon kohden for over a month on this intermittent issue and so far, have no information from them.From what we currently know this problem is not related to the actual physical device named in this report but more of a "system" issue.In the past, this problem would go away within 24-48 hours and not re-appear.Then it would re-appear on a different device.Investigation result: device was put into service on 10/28/2018.Warranty expires 10/27/2023.There are no other service notifications created for this device.Per our nk technical and integration lead, the root cause of the reported communication loss issue was due to customer misconfiguring their dhcp server.Misconfiguration caused duplicate ip addresses which in turn caused the gz telemetry devices to change ip mid-monitoring of a patient.Between the time frame of march 23rd to april 11th 2019, there was daily communication between nk engineers and the following (b)(6) heath personnel: (b)(6).On march 27th, 2019 the communication loss and registration error were resolved by customer changing the load balance setting to off.On april 10th, 2019 further communication loss was resolved by customer changing the lease period on the secondary dhcp server to mirror that of the primary dhcp server.The server was restarted after changes were applied.The troubleshooting details support customer (b)(6) statement that "from what we currently know this problem is not related to the actual physical device named in this report but more of a "system" issue." the troubleshooting details do not support customer (b)(6) statement that "nihon kohden telemetry transmitter gz130pa experienced an issue which caused both the war-room central nursing station (cns) and the nursing floor registered nursing station (rns) to show 'communication loss," resulting in the patient waveform to not be watched." the communication loss issue and the resulting loss of patient monitoring was caused by incorrect settings on the customer it network that underlies nk's patient monitoring devices.Further, the communication loss messages displayed was the normal functioning of the device.The purpose was to alert user of the communication issue detected, and thus the impact to patient monitoring.Therefore, it is concluded that nk devices were operating as intended.

Event Description

The customer stated that the gz-130pa transmitter experienced an issue which caused both the war-room central nursing station (cns) and the nursing floor registered nursing station (rns) to show 'communication loss," resulting in the patient waveform to not be watched.

Event Description

The customer stated that the gz-130pa transmitter experienced an issue which caused both the war-room central nursing station (cns) and the nursing floor registered nursing station (rns) to show 'communication loss," resulting in the patient waveform to not be watched.

Manufacturer Narrative

H10: additional narrative: written statement from (b)(6), clinical risk analyst from bay health medical center: "nihon kohden telemetry transmitter gz130pa experienced an issue which caused both the war-room central nursing station (cns) and the nursing floor registered nursing station (rns) to show 'communication loss", resulting in the patient waveform to not be watched.This problem has been experienced several times when trying to begin use of a telemetry box, but this is the 2nd time a working box on a patient suddenly experienced the issue and dropped out.We have been working with the vendor nihon kohden for over a month on this intermittent issue and so far, have no information from them.From what we currently know this problem is not related to the actual physical device named in this report but more of a "system" issue.In the past, this problem would go away within 24-48 hours and not re-appear.Then it would re-appear on a different device." service requested: troubleshooting.Service performed: troubleshooting.Investigation result: device was put into service on (b)(6) 2018.Warranty expires (b)(6)2023.There are no other service notifications created for this device.From customer's statement, it is unclear who from nihon kohden (nk) has been working on this issue.Per attached medwatch form filed by customer, the date of the event was reported as (b)(6) 2019.Per email from nk technical and integration lead, aaron raine, the root cause of the reported communication loss issue was due to customer misconfiguring their dhcp server.Misconfiguration caused duplicate ip addresses which in turn caused the gz telemetry devices to change ip mid-monitoring of a patient.Between the time frame of (b)(6) 2019, there was daily communication between nk engineers and the following bay heath personnel: (b)(6) (b)(6), sterling townsend, (b)(6), (b)(6), (b)(6) (b)(6), (b)(6), (b)(6), (b)(6).On (b)(6) 2019 the communication loss and registration error were resolved by customer changing the load balance setting to off.On (b)(6), 2019 further communication loss was resolved by customer changing the lease period on the secondary dhcp server to mirror that of the primary dhcp server.The server was restarted after changes were applied.The troubleshooting details support customer sharon (b)(6) statement that "from what we currently know this problem is not related to the actual physical device named in this report but more of a "system" issue." the troubleshooting details do not support customer sharon (b)(6) statement that "nihon kohden telemetry transmitter gz130pa experienced an issue which caused both the war-room central nursing station (cns) and the nursing floor registered nursing station (rns) to show 'communication loss", resulting in the patient waveform to not be watched." the communication loss issue and the resulting loss of patient monitoring was caused by incorrect settings on the customer it network that underlies nk's patient monitoring devices.Further, the communication loss messages displayed was the normal functioning of the device.The purpose was to alert user of the communication issue detected, and thus the impact to patient monitoring.Therefore, it is concluded that nk devices were operating as intended.D11& c2 concomitant medical products: the central nurses station (cns) and the remote nurses station (rns) were both used in conjunction with the gz-130pa transmitter.

• Brand Name: GZ-130PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 8610341
• MDR Text Key: 147328972
• Report Number: 8030229-2019-00152
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• Combination Product (y/n): N
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2019
• Distributor Facility Aware Date: 07/09/2019
• Device Age: 25 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2019
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: CNS.RNS.