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

Model Number	GZ-140P
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this gz transmitter is not outputting any sound.There was no patient injury reported.
Additional 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 or Problem Description
The customer reported that this gz transmitter is not outputting any sound.There was no patient injury reported.
Additional 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.
Event or Problem Description
The customer reported that this gz transmitter is not outputting any sound.There was no patient injury reported.
Additional Manufacturer Narrative
Udi related data quality updates only corrected information: d1 brand name: corrected the brand name from gz-140pa to gz-140p.D2b product code: corrected the product code from drt to mhx.D4 additional device information / model #: corrected the model # from gz-140pa to gz-140p.D4 additional device information / catalog #: corrected the catalog # from gz-140pa to gz-140p.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a, per the fda request.Additional information: b4 data of this report g6 type of report h2 if follow up, what type?.

• Brand Name: GZ-140P
• Common Device Name: 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
• Report Number: 8030229-2023-03678
• Device Sequence Number: 7252942
• Product Code: MHX
• UDI-Device Identifier: 04931921128244
• UDI-Public: (01)04931921128244(21)305
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K163459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GZ-140P
• Device Catalogue Number: GZ-140P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 11/03/2023; 11/03/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 11/06/2023; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS; CNS; CNS
• Patient Sex: Unknown