MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120PA; TRANSMITTER

Model Number GZ-120PA

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this unit will power off on its own.According to the customer, there was no error messages displayed.The customer will send in the unit to be exchanged.It is unknown if the unit was in patient use at the time.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.

Event Description

The customer reported that this unit will power off on its own.There was no patient injury reported.

Event Description

The customer reported that this unit will power off on its own.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this unit will power off on its own.According to the customer, there was no error messages displayed.The customer will send in the unit to be exchanged.It is unknown if the unit was in patient use at the time.There was no patient injury reported.Investigation summary: the nk repair center received the device, duplicated the issue, and found that the device had an electronic failure and that there was a rattling noise from inside the device.Based on the device evaluation it is possible that the electronic failure of the device may be attributed to physical damage to the internal components of the device, which can occur through user mishandling.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 02/20/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/28/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have that information.B6 attempt # 1: 02/20/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/28/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have that information.B7 attempt # 1: 02/20/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/28/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have that information.D10 attempt # 1: 02/20/2023 emailed the customer via microsoft outlook for patient and device information: no reply was received.Attempt # 2: 02/22/2023 emailed the customer via microsoft outlook for patient and device information: no reply was received.Attempt # 3 02/28/2023 emailed the customer via microsoft outlook for patient and device information: the customer replied by stating; i do not have that information.Additional information: b4 date of this report d9 device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow up, what type? h3 device evaluated by manufacturer? h10 additional manufacturer narrative manufacturer references # (b)(4) follow up 001.

• Brand Name: GZ-120PA
• 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: 16517763
• MDR Text Key: 311497967
• Report Number: 8030229-2023-03342
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• 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: 06/06/2023

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-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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