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

Model Number GZ-130PA

Device Problems Battery Problem (2885); Protective Measures Problem (3015)

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

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their gz battery warning did not appear or alarm to notify the staff of a dying battery.Because the device did not alarm, the patient was not being monitored for quite some time until someone from their staffed noticed it.No known harm or injury occurred.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: concomitant medical device: the following device was used in conjunction with the gz transmitter: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni.

Event Description

The customer reported that their gz battery warning did not appear or alarm to notify the staff of a dying battery.Because the device did not alarm, the patient was not being monitored for quite some time until someone from their staffed noticed it.No known harm or injury occurred.

Event Description

The customer reported that the battery warning/alarm did not appear on the gz transmitter to notify the staff of a dying battery.As a result, the patient was not being monitored for quite some time until a staff member noticed it.No known harm or injury occurred.

Manufacturer Narrative

Details of complaint: the customer reported that the battery warning/alarm did not appear on the gz transmitter to notify the staff of a dying battery.As a result, the patient was not being monitored for quite some time until a staff member noticed it.No harm or injury was reported.Investigation summary: low battery message is a message displayed on the cns screen, on the patient tile, indicating the remaining battery level of a monitored transmitter device.There are four levels of transmitter battery remaining level indicators.When the battery is weak, the change battery message is displayed as shown.When the battery has run out, the symptoms would be a comm loss, or a signal loss displayed at the cns.The nature of the no battery alarm was investigated under (b)(4).A gz displays the remaining battery power in the following 4 categories depending on the battery voltage.Fine, save, weak, and out.An alarm of "battery weak" goes off at the state of "weak." while checking the log, no history was found to be changed from "save" to "weak." in other words, it is supposed that the sudden voltage down occurred before changing to "weak" and then the power turned off.Although the log did not reveal anything more than the above, this phenomenon might happen when using unspecified batteries.As described in the operator's manual (0614-907505f section 4 batteries), using unspecified batteries may result in short battery life or reduced performance resulting in unstable measurement.Please use specified batteries.There is no indication of device malfunction.This device was installed on (b)(6) 2021 with no history of malfunction, and no recurrence of the event.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14465922
• MDR Text Key: 300353589
• Report Number: 8030229-2022-02837
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• 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: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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: CENTRAL NURSE'S STATION (CNS); CENTRAL NURSE'S STATION (CNS)