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

Model Number GZ-130PA

Device Problem Communication or Transmission Problem (2896)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that gz is dropping off randomly.The patients have been switched to bsm-1700 transport till issue is resolved.There was no patient injury 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.Attempt # 1: 06/28/2021 emailed the customer via microsoft outlook for patient information: the customer replied by simply stating: i am not authorized to release this information.Attempt # 1: 06/28/2021 emailed the customer via microsoft outlook for patient information: the customer replied by simply stating: i am not authorized to release this information.Attempt # 1: 06/28/2021 emailed the customer via microsoft outlook for patient information: the customer replied by simply stating: i am not authorized to release this information.Additional model information: concomitant medical device: ni, model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.

Event Description

The customer reported that the gz monitor is dropping off randomly.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitter was randomly dropping off the network.No harm or injury was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The customer was requesting on-site support to resolve the issue.No further issues were reported.The error message notifies the clinician that the gz-130pa is out of the radio wave range of the wireless local area network or that there is an error or mistake in the wireless local area network identification process or its settings.The causes associated with the issue are related to the hospital's network environment.The error message is used to notify the clinician of a network issue and is unlikely to be related to a device malfunction.A serial number review of the reported device does not reveal additional related complaints.

Event Description

The customer reported that the gz transmitter was randomly dropping off the network.There was no patient injury reported.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12162620
• MDR Text Key: 261774662
• Report Number: 8030229-2021-00403
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• 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
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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: NI.; NI.