MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER

Model Number GZ-130PA

Device Problem Patient Data Problem (3197)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.

Manufacturer Narrative

The biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well issue but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.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 field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: a2: a6.B6: b7.D10: attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: (b)(6 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.

Event Description

The biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.

Manufacturer Narrative

Incident summary: the biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well issue but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.Investigation summary: multiple follow-up requests regarding the return of the device were made to the customer, but the customer has been unresponsive to the phone call messages and emails sent for the return of this device.A definitive root cause could not be determined since we have not received the device for evaluation.Possible cause may include hardware component failure due to physical damage or fluid intrusion from user mishandling, electrical damage from improper battery usage, or wear-and-tear which depends on device age and frequency of use.Review of the complaint device's serial number does not show other complaints.The complaint could not be confirmed as we have not received the device after multiple follow-up requests.Nk will continue to monitor and trend similar complaints.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 12/28/2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/12/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 01/18/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.

• Brand Name: GZ-130PA
• 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: 18540550
• MDR Text Key: 333548513
• Report Number: 8030229-2024-04029
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2022
• 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: CNS.; CNS.