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

Model Number GZ-130PA

Device Problems Battery Problem (2885); Power Problem (3010); Wireless Communication Problem (3283)

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

Event Date 08/15/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the gz transmitter in hi-q view disconnected from the g9 monitoring unit without warning on (b)(6) 2023.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the gz transmitter in hi-q view disconnected from the g9 monitoring unit without warning on (b)(6) 2023.There were no reports of patient harm.Nkc reviewed the logs and confirmed that the central nurse's station (cns) displayed an error message stating "telemetry not connected" due to the battery being discharged, leaving no power to the gz transmitter or moving it out of the wireless lan range.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 devices were used in conjunction with the gz transmitter: cns: model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 27/08/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.G9 monitoring unit.Model #: cu-192r.Serial #: (b)(6).Device manufacturer data: 03/09/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz transmitter in hi-q view disconnected from the g9 monitoring unit without warning on 08/03/2023.There were no reports of patient harm.Nkc reviewed the logs and confirmed that the central nurse's station (cns) displayed an error message stating "telemetry not connected" due to the battery being discharged, leaving no power to the gz transmitter or moving it out of the wireless lan range.Investigation summary: investigation of the device logs for the cns sn:(b)(6).Was able to confirm that the cns received a "telemetry not connected" error which would indicate that the connection between the gz and the g9 was lost.This error was a result of the gz losing power.It was concluded that the two probable causes for no alarm for low battery and/or "telemetry not connected" error message are related to the use of unspecified batteries.The batteries recommended in the operator's manual of the gz-130p are the only batteries that were verified to operate well with the device.The internal resistance of the battery will determine how well it operates with the gz-130p, and it cannot be determined with battery specifications alone.The root cause has been identified as the use of non-specified batteries.There is no evidence of an nk device malfunction that may have contributed to the reported issue.The customer had changed the type of batteries used to resolve the issue.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 attempt # 1: 08/16/2023 emailed the bme for the patient information: no reply was received.Attempt # 2: 08/22/2023 emailed the bme for the patient information: no reply was received.Attempt # 3: 08/24/2023 emailed the bme for the patient information: no reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the gz transmitter: cns: model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 27/08/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.G9 monitoring unit model #: cu-192r.Serial #: (b)(6).Device manufacturer data: 03/09/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the gz transmitter in hi-q view disconnected from the g9 monitoring unit without warning on 08/03/2023.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: 17721926
• MDR Text Key: 323104171
• Report Number: 8030229-2023-03763
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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: 10/23/2023
• 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 MONITORING UNIT; G9 MONITORING UNIT