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

Model Number GZ-130PA

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the transmitter (gz) went offline without alerting with a low battery alarm.Bme stated that the customer would like nihon kohden to review the logs.No patient harm was reported.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 anything more than the above, but it is presumable that 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 (b)(6).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 confirmed the reported issue.Unfortunately, a definitive root cause was not determined.However, based on the available information, it is highly likely that 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, using unspecified batteries may result in short battery life or reduced performance resulting in unstable measurements and can lead to power-related issues.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) ) (on (b)(6) 2023), found there was only one occurrence for each device issue in the past (3) three years.However, there was one previous ticket # (b)(4) (mdr 03645-300333099) on (b)(6) 2023, for this gz-130pa, serial number (b)(6) , for the same issue as reported for this ticket (b)(4).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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: 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: 08/27/2020.Unique identifier (udi) #: (b)(4).G9 monitor: model #:cu-192ra.Serial #: (b)(6).Device manufacturer data: 09/04/2020.Unique identifier (udi) #: (b)(4).

Event Description

The biomedical engineer (bme) reported that the gz transmitter went offline without alerting with a low battery alarm.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: 17339495
• MDR Text Key: 319760336
• Report Number: 8030229-2023-03652
• 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
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• 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: 06/20/2023
• 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; G9 MONITOR