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

Model Number GZ-130PA

Device Problems No Audible Alarm (1019); Battery Problem (2885)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

The customer reported that the gz transmitter battery spontaneously died without warning.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the gz transmitter battery spontaneously died without warning.According to the customer, the unit died, but they're not seeing any event showing a change trans battery for this unit.The customer wants this investigated to see what caused the event.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: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6: attempt # 1: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7: attempt # 1: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.D10: attempt # 1: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitter battery spontaneously died without warning.According to the customer, the unit died, but they're not seeing any event showing a change trans battery for this unit.The customer wants this investigated to see what caused the event.There was no patient injury reported.Investigation summary: review of the customer's complaint history shows similar complaints under the following tickets: (b)(4) and found to be due to the customer using batteries not recommended for use with the gz transmitter.The gz operator's manual recommends using medipower alkaline batteries or panasonic nimh batteries as these have been verified to operate well with the device.Manufacturer references # (b)(4)- 174871 follow up 001.

Event Description

The customer reported that the gz transmitter battery spontaneously died without warning.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: 17108003
• MDR Text Key: 317767008
• Report Number: 8030229-2023-03604
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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.