MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120PA; TRANSMITTER

Model Number GZ-120PA

Device Problems Application Program Problem (2880); Output Problem (3005)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that they had lost data for 2 patients, they disappeared from the patient tile on the central nurse's station (cns), and they were no longer getting waveforms and the patient name and id disappeared.Patient was admitted to the cns.Then they saw that the patient disappeared off the patient tile.It seemed as if they were not admitted to the cns.The first instance happened yesterday on (b)(6) 2020 at around 7:30 am to 8:00 am when they noticed that the patient disappeared.They re-entered the patient id, and they were able to put them back on the cns.The second instance happened on (b)(6) 2020 at 9:20 am, the patient was admitted at 7:30 am and they noticed the patient disappeared at 9:20 am.All the data from 7:30am to 9:20am was lost due to this.This patient was on a gz-120pa sn:(b)(4) software version (b)(4).No patient harm was reported.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 field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The nurse reported that they had lost data for 2 patients, they disappeared from the patient tile on the central nurse's station (cns), and they were no longer getting waveforms and the patient name and id disappeared.Patient was admitted to the cns.Then they saw that the patient disappeared off the patient tile.It seemed as if they were not admitted to the cns.The first instance happened yesterday on (b)(6) 2020 at around 7:30 am to 8:00 am when they noticed that the patient disappeared.They re-entered the patient id, and they were able to put them back on the cns.The second instance happened on (b)(6) 2020 at 9:20 am, the patient was admitted at 7:30 am and they noticed the patient disappeared at 9:20am.All the data from 7:30 am to 9:20 am was lost due to this.This patient was on a gz-120pa sn: (b)(4).Software version (b)(4).No patient harm was reported.

Manufacturer Narrative

Details of the complaint: customer reported patient was admitted to the central monitor but after about two hours, patient tile disappeared and patient data is lost.The first instance happened yesterday((b)(6) 2020) at around 7:30am to 8:00am when they noticed that the patient disappeared.They re-entered the patient id and they were able to put them back on the cns.The second instance happened today (b)(6) 2020 at 9:20am, the patient was admitted at 7:30 am and they noticed the patient disappeared at 9:20am.All the data from 7:30am to 9:20am was lost due to this.This patient was on a gz-120pa (b)(6) sw 2.22 limited information regarding the bedside monitor and/or telemetry transmitter was provided.Cns logs were collected and sent to manufacturer for analysis.Investigation conclusion: the patient with patient id (b)(6) was admitted to the bedside monitor with "024-4n".In addition, we were able to confirm the log of discharge from the bedside monitor instead of the central monitor at that date and time.Alarmreport.Csv (8056): information, 2020/10/06 9:26:44, nkcns-9701,2001, admitted, bed, 024-4n, patient ,, alarmreport.Csv (19765): information, (b)(6) 2020 18:31:02, nkcns-9701,2001, discharged, bed, 024-4n, patient ,, alarmreport.Csv (28942): information, (b)(6) 2020 9:49:19, nkcns-9701,2001, admitted, bed, 024-4n, patient ,, alarmreport.Csv (28949): information, (b)(6) 2020 9:49:13, nkcns-9701,2001, discharged, bed, 024-4n, patient ,, alarmreport.Csv (29840): information, (b)(6) 2020 9:14:00, nkcns-9701,2001, admitted, bed, 024-4n, patient ,, alarmreport.Csv (29844): information, (b)(6) 2020 9:13:55, nkcns-9701,2001, discharged, bed, 024-4n, patient ,, the cause is thought to be the operation of discharging the bedside monitor.Service history for this customer shows a prior incident (ticket 66494) in which customer reported admit/discharge/transfer (adt) issues with gz transmitters.The root cause was determined to be related to user's workflow excerpt from ticket 66494: it has been narrowed down that the patient id# is not being entered for patients that are being transferred directly into their icu from other facilities.When the hospital receives a transfer from another hospital, they admit the patient by just inputting the first and last name because the patient id # hasn't been created yet.It takes the facility 30 minutes to an hour to assign a patient id# to the patient and once it's assigned, no one is going back into the cns to put that number in.When the morning shift gets in, they notice the patient id# is missing, but the number was never entered into the system.This is a procedural issue and needs to be corrected by the facility to ensure the patient id # is being inputted once it's available.This will fix the issues with patient id #'s missing from the station.Having examined the data under the current ticket (91997), the root cause was determined to be user error: discharge of patient operation performed.Service history for this customer shows the issue has not repeated.The following fields contains no information (ni), as attempts to obtain information were made, but not provided.Additional model information: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The nurse reported that they had lost data for 2 patients, they disappeared from the patient tile on the central nurse's station (cns), and they were no longer getting waveforms and the patient name and id disappeared.Patient was admitted to the cns.Then they saw that the patient disappeared off the patient tile.It seemed as if they were not admitted to the cns.The first instance happened yesterday on (b)(6) 2020 at around 7:30am to 8:00am when they noticed that the patient disappeared.They re-entered the patient id, and they were able to put them back on the cns.The second instance happened on (b)(6) 2020 at 9:20am, the patient was admitted at 7:30 am and they noticed the patient disappeared at 9:20am.All the data from 7:30am to 9:20am was lost due to this.This patient was on a gz-120pa (b)(6) software version 2.22.No patient harm was reported.

• Brand Name: GZ-120PA
• 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
• MDR Report Key: 10789040
• MDR Text Key: 229935788
• Report Number: 8030229-2020-00656
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GZ-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1