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

Model Number GZ-130PA

Device Problem Application Program Problem (2880)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the gz transmitter discharged the patient without user intervention.Nk ts is currently working to resolve the issue.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 field contains no information (ni), as attempts to obtain information were made, but not provided: concomitant medical device.

Event Description

The customer reported that the gz transmitter discharged the patient without user intervention.

Event Description

The customer reported that the gz transmitter discharged the patient without user intervention.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitter discharged the patient without user intervention.No patient harm or injury was reported.Investigation summary: the customer suspected the issue was due to not having rebooted the servers for a while.A review of the history of the serial number identified no similar events.Based on the available information, a definitive root cause could not be identified.It is possible that the device was accidentally being discharged due to the screen not being locked.If the screen is not locked, the patient's movements may cause actions on the screen of the device to be triggered and may lead to discharging of the device.Improvements were made on the lock screen functionality of the gz device to have it start on a locked screen.Per mmbex 171 [a] - co-3349, the version update to v02-22 (complaint devices are in an earlier version, v02-20) added a mode to start with a locked screen when the gz starts.Additionally, when the gz starts up, the key lock state at the time of the previous power off is continued.Additional information: b4 date of this report d8 was this device serviced by a third party? g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• 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 ; 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: 10439971
• MDR Text Key: 204185473
• Report Number: 8030229-2020-00463
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2020,02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2020
• Distributor Facility Aware Date: 07/23/2020
• Device Age: 42 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2020
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2017
• 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