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

Model Number	GZ-120P
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Protective Measures Problem (3015); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the gz transmitter experienced intermittent ecg waveforms and did not display an error message.There was no physical damage or patient involved.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: cns-6801a.Model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 17/08/2017.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitter experienced intermittent ecg waveforms and did not display an error message.Not in patient use.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the gz transmitter experienced intermittent ecg waveforms and did not display an error message.There was no physical damage or patient involved.Investigation summary: evaluation of the returned device was not able to duplicate the reported issue of ecg cutting out.The unit was able to monitor ecg and respiratory rate normally.It is likely the wlan board was damaged and was preventing ecg values from being sent to the cns.Physical damage to the screen was also observed.The physical damage may have also contributed to wlan board damage.Physical damage is likely to occur as a result of mishandling.Mishandling of a device can be related to the dropping of a device, hard impacts, or improper use.Damage to the device can extend to internal components vital for operation.The root cause is likely related to physical damage due to mishandling of the device based on the physical damage observed on the unit.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns-6801a, model #: pu-681ra, serial #: (b)(6), device manufacturer data: 17/08/2017, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitter experienced intermittent ecg waveforms and did not display an error message.Not in patient use.
Additional Manufacturer Narrative
**udi related data quality updates** corrected information: d1 brand name: corrected the brand name from gz-120pa to gz-120p.D2b product code: corrected the product code from drt to mhx.D4 additional device information / model #: corrected the model # from gz-120pa to gz-120p.D4 additional device information / catalog #: corrected the catalog # from gz-120pa to gz-120p.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitter experienced intermittent ecg waveforms and did not display an error message.Not in patient use.

• Brand Name: GZ-120P
• Common Device Name: 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: 18397917
• Report Number: 8030229-2023-03950
• Device Sequence Number: 19825435
• Product Code: MHX
• UDI-Device Identifier: 04931921117392
• UDI-Public: (01)04931921117392(21)100
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K153707
• 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,Followup
• Report Date (Section B): 08/09/2024
• 2 Devices were Involved in the Event: 1 2

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 03/01/2024; 03/01/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 03/06/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2016
• 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: CNS; CNS; CNS
• Patient Sex: Unknown