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

Model Number GZ-130PA

Device Problems Alarm Not Visible (1022); Protective Measures Problem (3015)

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

Event Date 05/22/2023

Event Type  malfunction  

Event Description

The biomedical engineer reported that on (b)(6) 2023 around 10:21 am the gz monitor did not alarm when the battery was low.The gz monitor stopped working and at the cns it read "telemetry not connected".The heart rate (hr) stopped showing on the cns because it was being monitored by the gz monitor.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer reported that on (b)(6) 2023 around 10:21 am the gz monitor did not alarm when the battery was low.The gz monitor stopped working and at the cns it read "telemetry not connected".The heart rate (hr) stopped showing on the cns because it was being monitored by the gz monitor.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.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: b7 additional device information: d10 concomitant medical device: the following device(s) was used in conjunction with the gz transmitter: model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 08/27/2020.Unique identifier (udi) #: (b)(6).G9: model #:cu-192ra.Serial #: (b)(6).Device manufacturer data: 09/04/2020.Unique identifier (udi) #:(b)(6).

Manufacturer Narrative

Details of complaint: on (b)(6) 2023, (at approximately 10:21 am), the customer experienced an issue with the device (gz-130pa, serial number: (b)(6)), as the low battery alarm did not display, while using a g9 device, (cu-192ra, serial number: (b)(6)), in hi-q view.When the gz power died, the cns (central nursing station) device, (pu-681ra, serial number: (b)(6)), displayed an error message "telemetry not connected".The hr (heart rate) stopped displaying on the cns because it was being monitored by the gz pack.The device was in patient use, when the issue occurred, however, there was no patient injury, no harm, nor any adverse event, due to the reported issue.Customer said he wants to document this instance and sent the cns, g9, & gz logs for nihon kohden review.This issue occurred on a second incident on ticket number (b)(4) that a mdr will be filed on that ticket.Investigation summary: the gz displays the remaining battery power in the following four types according to the battery voltage, (fine, save, weak and out).The "battery weak" alarm sounds at the time of "weak".When nihon kohden investigator analyzed the log, they were unable to find any trace of the transition from "save" to "weak".In other words, it is presumed that a sudden voltage drop occurred before the transition to "weak" and the power was turned off.From the log, nk investigator could not find out anything more than the above, but it is presumable this event may occur if a battery, other than the recommended one is used.According to the information provided by the customer, the nibp measurement was performed at 10:15 on may 22nd.Based on the information, it was speculated that the power supply was cut off due to the possibility of a sudden voltage, drop during the nibp measurement.Root cause analysis/results: based on the reported information, nk investigator were able to confirm the reported issue.Unfortunately, a definitive root cause was not determined.However, based on the available information, it is highly likely a power related issue, (such as power supply being cut off and/or a sudden surge in voltage), could have led to and/or caused or contributed to the reported issues.Although the investigation did not reveal anything more than the findings above, this phenomenon might happen when using unspecified batteries.As described in the operator's manual, (refer to the batteries section), using unspecified batteries may result in short battery life or reduced performance resulting in unstable measurements (and can lead to power related issue).It is recommended for the customer to use the correct specified batteries.Review of the history for the following devices, g9 device:cu-192ra (serial number: (b)(6)) and cns device: pu-681ra (serial number: (b)(6)) found there was only one occurrence for each device issue, for this issue, found in the past (3) three years.However, there were 2 (two) occurrences found for gz device: gz-130pa (serial number: (b(6)), one issue under this ticket #(b)(4) and another ticket under # (b)(4) (on 06/20/2023), for the same issue, at the same facility, for the same device, (possibly due to a surge in power/power related issue at the facility).Based on trending review, these issues are isolated incidents and a significant trend for these devices, facility, and issues, do not suggest any design/manufacturing issue nor warrant any further investigation or corrective action.Additional device information: d10 concomitant medical device: the following device(s) was used in conjunction with the gz transmitter: cns: model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 08/27/2020.Unique identifier (udi) #: (b)(4).G9: model #:cu-192ra.Serial #: (b)(6).Device manufacturer data: 09/04/2020.Unique identifier (udi) #: (b)(4).

Event Description

The biomedical engineer reported that on (b)(6) 2023 around 10:21 am the gz monitor did not alarm when the battery was low.The gz monitor stopped working and at the cns it read "telemetry not connected".The heart rate (hr) stopped showing on the cns because it was being monitored by the gz monitor.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: 17222038
• MDR Text Key: 318116049
• Report Number: 8030229-2023-03642
• 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: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• 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; G9 CORE UNIT; G9 CORE UNIT