MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-140PA; TRANSMITTER

Model Number	GZ-140PA
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	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the gz transmitter would not show the ecg waves or numerics on the wireless surge solution (wss) or on the transmitter, but it was showing the respiration rate.They tried known working leads, but the issue remained.They swapped the unit with a working transmitter to continue patient monitoring.There were no reports of harm while 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: wireless surge solution (wss), model #: v6kh977, serial #: (b)(6), 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 would not show the ecg waves or numerics on the wireless surge solution (wss) or on the transmitter.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the gz transmitter would not show the ecg waves or numerics on the wireless surge solution (wss) or on the transmitter.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the gz transmitter would not show the ecg waves or numerics on the wireless surge solution (wss) or on the transmitter, but it was showing the respiration rate.They tried known working leads, but the issue remained.They swapped the unit with a working transmitter to continue patient monitoring.There were no reports of harm while in patient use.Investigation summary: nihon kohden (nk) received the device on 05/12/2023.Nk repair center (rc) evaluated the device on 06/19/2023.Nk rc could not duplicate the complaint.No problems with the device were found after testing.The unit was tested per the operator's manual and administrator's guide and operated to the manufacturer's specifications.A definitive cause for the issue could not be determined since the complaint could not be duplicated.Possible causes of the issue may include a loose connection of the lead set with the ecg socket, the use of a defective lead set, or user error in the device set-up.A review of the device's serial number does not show any other complaints.Corrective and preventative action is not required at this time.Device evaluation did not find any malfunction.A review of the customer's complaint history does not show any trends or other related complaints.Nk will continue to monitor and trend similar complaints.Attempt # 1: 05/03/2023 emailed the customer for patient information and concomitant medical device: no reply was received.Attempt # 2: 05/04/2023 emailed the customer for patient information and concomitant medical device: the bme provided the concomitant medical device, but the patient information was "unknown." additional device information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: wireless surge solution (wss).Model #: a-wss-001-za.Serial #: (b)(6).Device manufacturer data: 21/01/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

• Brand Name: GZ-140PA
• 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: 16907554
• Report Number: 8030229-2023-03535
• Device Sequence Number: 12471863
• Product Code: DRT
• UDI-Device Identifier: 04931921128244
• UDI-Public: 04931921128244
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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-140PA
• Device Catalogue Number: GZ-140PA
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2018
• 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: WIRELESS SURGE SOLUTION (WSS); WIRELESS SURGE SOLUTION (WSS)
• Patient Sex: Unknown