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

Model Number	GZ-120P
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the gz transmitter had intermittent waveform dropout and flatlining.No physical damage or fluid intrusion was reported.No patient harm was reported.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.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6.B6 - b7.D10.Attempt # 1: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied that none of the requested information can be provided.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: central nurse's station (cns): model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer reported that the gz transmitter had intermittent waveform dropout and flatlining.No physical damage or fluid intrusion was reported.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitter had intermittent waveform dropout and flatlining.No physical damage or fluid intrusion was reported.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the gz transmitter had intermittent waveform dropout and flatlining.No physical damage or fluid intrusion was reported.No patient harm was reported.Investigation summary: the complaint device was received by nk's repair center (rc).The device was evaluated, and the complaint could not be duplicated since the device was unable to power up.No significant physical damage was observed on the device.Some scratches were found on the touchscreen.The battery connectors showed signs of liquid intrusion.The battery cover was also missing.A definitive root cause could not be determined since we could not duplicate the issue during evaluation.Possible causes may include circuit board failure due to electrical damage from user error with battery usage.This may include using old batteries, leaving old batteries in the battery compartment while not in use which can lead to battery leakage over time and damage internal components, or inserting batteries in the wrong orientation.A review of the complaint device's serial number did not show other complaints.A review of the customer's complaint history did not show any trend for this issue and device.Nk will continue to monitor and trend similar complaints.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: central nurse's station (cns): model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na **udi related data quality updates** corrected information: d1 brand name: corrected the brand name from gz-120pa to gz-120p.D2b device 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 pi information.G4 premarket identification / pma/510(k) number: corrected the 510(k) # from k153707 to k163459.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.

• 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: 19203426
• Report Number: 8030229-2024-04281
• Device Sequence Number: 8106838
• Product Code: MHX
• UDI-Device Identifier: 04931921117392
• UDI-Public: (01)04931921117392(21)182
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 01/17/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2017
• 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.
• Patient Sex: Unknown