MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-140PA; TRANSMITTER

Model Number GZ-140PA

Device Problems No Audible Alarm (1019); Protective Measures Problem (3015)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

The customer reported that this gz transmitter is not outputting any sound.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this gz transmitter is not outputting any sound.The customer will send in the unit to be repaired.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 gz transmitter is not outputting any sound.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this gz transmitter is not outputting any sound.The customer will send in the unit to be repaired.There was no patient injury reported.Investigation summary: nihon kohden (nk) received the complaint device on 07/27/2023.Nk repair center (nk rc) evaluated the complaint device on 08/02/2023 and duplicated the problem.Nk rc opened the unit and swapped the speaker from another unit that was working fine.After switching this, they got a sound from the unit and determined that the problem was related to the speaker component.The cause of the issue was hardware component failure of the speaker.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-140PA
• 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: 17484748
• MDR Text Key: 321407419
• Report Number: 8030229-2023-03678
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921128244
• UDI-Public: 04931921128244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163459
• 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: 11/06/2023

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-140PA
• Device Catalogue Number: GZ-140PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• 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: CNS; CNS