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

Model Number GZ-130PA

Device Problems Output Problem (3005); Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the gz telemetry transmitter did not alarm for low battery.They would like us to review the logs for 12/04/23 at 5:57am 20 min duration, to find out why find out why it never alarmed to change batteries.They believe when the batteries were changed, they were changed with depleted batteries because they only lasted 4 hours.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the gz telemetry transmitter did not alarm for low battery.They would like us to review the logs for 12/04/23 at 5:57am 20 min duration, to find out why find out why it never alarmed to change batteries.They believe when the batteries were changed, they were changed with depleted batteries because they only lasted 4 hours.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.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the gz telemetry transmitter.Central nurse's station model: cns-6801a sn: (b)(6).Device manufacturer date: 06/21/2022 unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned bedside monitor model: csm-1901a sn: (b)(6).Device manufacturer date: 09/07/2020 unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz telemetry transmitter did not alarm for low battery when it became depleted.No harm or injury was reported.Investigation summary: the customer thinks that when the batteries were changed, they were changed using depleted batteries instead of new ones because the batteries only lasted 4 hours.The device log files were sent in for analysis and nkc performed an investigation on them.Nkc analyzed the logs of all three devices: central nurse's station (cns) (pu-681ra, sn: (b)(6)); core unit g9 monitor (cu-192ra, sn: (b)(6)); gz transmitter (gz-130pa, sn: (b)(6)).Nkc was unable to confirm the reported issue during the time of the event because the logs did not reveal any clear "battery weak" error messages.As such, since the logs did not reveal any clear causes of the reported issue, no definitive root cause could be determined.Additionally, three good faith attempts were made to the customer for additional information on whether the batteries the customer was using were exhausted (depleted), but the customer was unresponsive to all attempts.Nka recommendations for the customer is to only use prcell intense batteries.Ensure the batteries are brand new and not depleted.Using mixed batteries, new and old batteries together, is not recommended as well.If the customer was using depleted or mixed batteries, it may shorten the battery life, and the performance of these batteries may deteriorate, possibly causing the measurements to become unstable.A serial number review of the reported device (gz-130pa, sn: (b)(6)) does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.Central nurse's station.Model: cns-6801a.Sn: (b)(6).Device manufacturer date: 06/21/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Core unit g9 monitor.Model: csm-1901a.Sn: (b)(6).Device manufacturer date: 09/07/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.

Event Description

The biomedical engineer (bme) reported that the gz telemetry transmitter did not alarm for low battery when it became depleted.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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18444952
• MDR Text Key: 331907710
• Report Number: 8030229-2024-03961
• 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: 03/15/2024

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: 12/05/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/23/2020
• 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-6801A (B)(6); CORE UNIT G9 MONITOR; CSM-1901A (B)(6)