MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CAP-ONE; CO2 SENSOR KIT

Model Number	TG-920P
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) received a report from the nurses that this etco2 sensor was reading intermittently while in patient use.When the bme tested the sensor, it was not reading at all.No patient harm was 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.Attempt # 1: 05/07/2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 05/14/2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: 05/21/2024 emailed the bme for all information in the ni list above: no reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the co2 sensor kit: co2 sensor kit - part model #: tg-920p serial #: (b)(4).Device manufacturer data: 11/03/2019 (mar.11, 2019) unique identifier (udi) #: (b)(4).Returned to nihon kohden: ni bedside monitor (bsm): model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) received a report from the nurses that this etco2 sensor was reading intermittently while in patient use.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) received a report from the nurses that this etco2 sensor was reading intermittently while in patient use.No patient harm was reported.
Additional Manufacturer Narrative
Original complaint: the biomedical engineer (bme) received a report from the nurses that this etco2 sensor was reading intermittently while in patient use.When the bme tested the sensor, it was not reading at all.No patient harm was reported.Investigation summary: as the reported device was not returned for evaluation, the reported issue could not be duplicated nor confirmed.As such, root cause cannot be determined.As the device is a sensor and cable, it is likely that the cable portion of the device has become damaged and could not longer take a reading.Cable damage can occur as a result of physical damage or wear and tear.Physical damage can occur to cables should they be bent and tugged on with excessive force resulting in internal wires breaking.Frequent pulling and bending of the cable can also cause wires to separate.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the co2 sensor kit: co2 sensor kit - part.Model #: tg-920p.Serial #: (b)(6).Device manufacturer data: 11/03/2019 (mar.11, 2019).Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from tg-920p to cap-one.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the pi information.This is a correction to the suspect medical device involved in the reported event, applicable to the unique device identifier (udi) information of the fda form 3500a.
Event or Problem Description
The biomedical engineer (bme) received a report from the nurses that this etco2 sensor was reading intermittently while in patient use.No patient harm was reported.
Additional Manufacturer Narrative
Original complaint: the biomedical engineer (bme) received a report from the nurses that this etco2 sensor was reading intermittently while in patient use.When the bme tested the sensor, it was not reading at all.No patient harm was reported.Investigation summary: as the reported device was not returned for evaluation, despite three good faith efforts attempted on 7/18/2024, 9/18/2924 and 10/08/2024.The reported issue could not be duplicated nor confirmed.As such, root cause cannot be determined.As the device is a sensor and cable, it is likely that the cable portion of the device has become damaged and could not longer take a reading.Cable damage can occur as a result of physical damage or wear and tear.Physical damage can occur to cables should they be bent and tugged on with excessive force resulting in internal wires breaking.Frequent pulling and bending of the cable can also cause wires to separate.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the co2 sensor kit: co2 sensor kit - part.Model #: tg-920p.Serial #: (b)(6).Device manufacturer data: 11/03/2019 (mar.11, 2019).Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.
Additional Manufacturer Narrative
Original complaint: the biomedical engineer (bme) received a report from the nurses that this etco2 sensor was reading intermittently while in patient use.When the bme tested the sensor, it was not reading at all.No patient harm was reported.Investigation summary: as the reported device was not returned for evaluation, despite three good faith efforts attempted on (b)(6) 2024.The reported issue could not be duplicated nor confirmed.As such, root cause cannot be determined.As the device is a sensor and cable, it is likely that the cable portion of the device has become damaged and could not longer take a reading.Cable damage can occur as a result of physical damage or wear and tear.Physical damage can occur to cables should they be bent and tugged on with excessive force resulting in internal wires breaking.Frequent pulling and bending of the cable can also cause wires to separate.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 b6 - b7 d10.Attempt # 1: (b)(6) 2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: (b)(6) 2024 emailed the bme for all information in the ni list above: no reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the co2 sensor kit: co2 sensor kit - part model #: tg-920p serial #: (b)(6), device manufacturer data: ((b)(6) 2019) unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned bedside monitor (bsm): model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from tg-920p to cap-one.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the pi information.This is a correction to the suspect medical device involved in the reported event, applicable to the unique device identifier (udi) information of the fda form 3500a.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h11 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) received a report from the nurses that this etco2 sensor was reading intermittently while in patient use.No patient harm was reported.

• Brand Name: CAP-ONE
• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 19404158
• Report Number: 8030229-2024-04316
• Device Sequence Number: 12499187
• Product Code: CCK
• UDI-Device Identifier: 04931921865750
• UDI-Public: (01)04931921865750(21)63799
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K040875
• 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,Followup
• Report Date (Section B): 10/16/2024

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-920P
• Device Catalogue Number: TG-920P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 10/15/2024; 10/14/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 10/07/2024; 10/15/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2022
• 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: BSM; BSM; BSM; BSM
• Patient Sex: Unknown