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
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.
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.

• 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
• MDR Report Key: 12243016
• Report Number: 2080783-2021-01432
• Device Sequence Number: 3671027
• Product Code: CCK
• UDI-Device Identifier: 04931921885635
• UDI-Public: 4931921885635
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2021
• Report Date (Section F): 07/28/2021

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 108
• Date Report Sent to FDA: 07/28/2021