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

Model Number GZ-140PA

Device Problems No Display/Image (1183); Communication or Transmission Problem (2896)

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

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the gz transmitter was not displaying waveforms, but all other parameters available.Issue was resolved by rebooting the unified gateway.No error messages displayed on the central nurse's stations (cns) when this was happening.No patient harm 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.Additional device information: concomitant medical device: the following devices were being used in conjunction with the gz transmitter.Central nurse's station: model: cns-6201a, sn: (b)(4).

Event Description

The biomedical engineer (bme) reported that the gz transmitter was not displaying waveforms, but all other parameters available.Issue was resolved by rebooting the unified gateway.No error messages displayed on the central nurse's stations (cns) when this was happening.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz transmitter was not displaying waveforms at the central nurse's station (cns), but all other parameters were available.The issue was resolved by rebooting the unified gateway (ug).No patient harm or injury was reported.Investigation summary: nihon kohden technical support (nk ts) requested assistance from clinical (cits) who rebooted the ug.The root cause is determined to be the facility's network environment.The ug reboot allowed the correct boot sequence for the gz transmitter to display all information to the cns.A review of the serial number history shows no recurrence of the reported issue.Because most network and comm loss issues are due to hospital network settings, connection errors, or other use errors, issues of this type are unlikely to be caused by a device malfunction.

Event Description

The biomedical engineer (bme) reported that the gz transmitter was not displaying waveforms, but all other parameters were available.Issue was resolved by rebooting the unified gateway.No error messages displayed on the central nurse's stations (cns) when this was happening.No patient harm reported.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10498423
• MDR Text Key: 207153813
• Report Number: 8030229-2020-00515
• 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: 02/28/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/06/2020
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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: CNS-6201A SN (B)(6); CNS-6201A SN (B)(6)