MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120P; TELEMETRY TRANSMITTER

Model Number	GZ-120P
Medical Device Problem Codes	Device Alarm System (1012); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that 80% of their gz transmitters were not alarming when the batteries were weak when on standby waiting to be used.The bme did not have a list of the affected gzs, but they were all gz-120s.This was discovered while they were in possession of the gz; the central nurse station (cns) showed "comm loss" and the gz never alarmed for a weak battery.The bme duplicated the issue using his cns and the gz provided in his lab.Technical support (ts) confirmed they were using procell constant and medcell batteries.Ts informed the bme theses were not the recommended batteries from the manual and provided them with the list of recommended batteries.The bme stated he will use the recommended batteries.Not in patient use.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 was used in conjunction with the gz transmitter: central nurse station (cns): model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Gz transmitters.Model #: gz-120p.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that 80% of their gz transmitters were not alarming when the batteries were weak when on standby waiting to be used.Not in patient use.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that 80% of their gz transmitters were not alarming when the batteries were weak when on standby waiting to be used.The bme did not have a list of the affected gzs, but they were all gz-120s.This was discovered while they were in possession of the gz; the central nurse station (cns) showed "comm loss" and the gz never alarmed for a weak battery.The bme duplicated the issue using his cns and the gz provided in his lab.Technical support (ts) confirmed they were using procell constant and medcell batteries.Ts informed the bme theses were not the recommended batteries from the manual and provided them with the list of recommended batteries.The bme stated he will use the recommended batteries.Not in patient use.Investigation summary: multiple attempts were made to collect additional information, but the customer was unresponsive.The issue of the weak battery alarm not alarming has been investigated in ticket (b)(4) (irc-239) and ticket (b)(4) (irc-371).The issue arises when a sudden voltage drop causes the unit to turn off prior to the battery status changing to "weak".Ticket (b)(4) identified that certain battery types can cause performance issues, while the investigation in ticket (b)(4) prompted a design change to the gz alarm behavior.The voltage threshold for the battery weak alarm was adjusted in software version 02-74.A significant trend has not been observed that would warrant any further corrective action.Nihon kohden will continue to trend and monitor.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 02/06/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 2: 02/11/2026 emailed the bme via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: 02/17/2026 emailed the bme via microsoft outlook for the information in the ni list above: no reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: central nurse station (cns): model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden:.Gz transmitters model #: gz-120p serial #: ni device manufacturer data: ni unique identifier (udi) #: (b)(4).Returned to nihon kohden:.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that 80% of their gz transmitters were not alarming when the batteries were weak when on standby waiting to be used.Not in patient use.

• Brand Name: GZ-120P
• Common Device Name: TELEMETRY 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: 24494990
• Report Number: 8030229-2026-06262
• Device Sequence Number: 10638214
• Product Code: MHX
• UDI-Device Identifier: 04931921117392
• UDI-Public: (01)04931921117392
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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
• Operator of Device: Health Professional
• Device Model Number: GZ-120P
• Device Catalogue Number: GZ-120P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL NURSE STATION; CENTRAL NURSE STATION; GZ TRANSMITTERS; GZ TRANSMITTERS
• Patient Sex: Unknown