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

Model Number GZ-140PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 04/20/2023

Event Type  malfunction  

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 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 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.

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
• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16907554
• MDR Text Key: 314979693
• Report Number: 8030229-2023-03535
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921128244
• UDI-Public: 04931921128244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• 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: WIRELESS SURGE SOLUTION (WSS); WIRELESS SURGE SOLUTION (WSS)