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 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this unit is having sporadic communication loss (comm loss).Cits started the packet capture processes (pcaps) during a meeting to discuss the reported issue.The customer later requested to stop the pcaps as they were getting comm loss on all gz transmitters every two minutes.The system engineer stopped the pcaps as requested by the customer.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 01/25/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/30/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 01/25/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/30/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 01/25/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/30/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.D4 serial number.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: ni serial #: ni device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: no.

Event Description

The customer reported that this unit is having sporadic communication loss (comm loss).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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18712631
• MDR Text Key: 336404515
• Report Number: 8030229-2024-04116
• Device Sequence Number: 1
• Product Code: DRT
• 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
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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.