MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION TG-970P; CO2 SENSOR KIT

Model Number	TG-970P
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 sleep, eeg, evs manager reported that they noticed the high values and went to check on the patient.They then decided to check other cables and found that this tg-970p, co2 sensor kit, was giving inaccurate reading.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the sleep, eeg, evs manager reported that they noticed high values and went to check on the patient.They then decided to check other cables and found that this tg-970p, co2 sensor kit, was giving inaccurate readings.No harm or injury was reported.Investigation summary: the customer did not provide the appropriate additional device information as requested.Nihon kohden (nk) was able to confirm the reported complaint, based on the reported information.A definitive root cause of the reported issue cannot be determined, as the issue is user dependent.However, it is possible during the installation process at the facility, the cable was damaged due to mishandling.Nk resolved the issue by providing a replacement cable, as requested.
Event or Problem Description
The sleep, eeg, evs manager reported that they noticed high values and went to check on the patient.They then decided to check other cables and found that this tg-970p, co2 sensor kit, was giving inaccurate readings.No patient harm was reported.

• Brand Name: TG-970P
• Common Device Name: CO2 SENSOR KIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• 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: 12242980
• Report Number: 8030229-2021-01432
• Device Sequence Number: 3681929
• Product Code: CCK
• UDI-Device Identifier: 04931921885635
• UDI-Public: 4931921885635
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K122214
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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
• Operator of Device: Health Professional
• Device Model Number: TG-970P
• Device Catalogue Number: TG-970P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NI.; NI.
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 108 KG