MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION OLG-2800A; CARBON DIOXIDE MONITOR

Model Number	OLG-2800A
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported that the co2 monitor was delivering inaccurate readings, and that it was being caused by the high flow rate of the nasal cannula.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 if additional information becomes available.
Event or Problem Description
The nurse reported that the co2 monitor was delivering inaccurate readings, and that it was being caused by the high flow rate of the nasal cannula.
Additional Manufacturer Narrative
Details of the complaint: on (b)(6) 2018, (b)(6) reported the co2 monitor olg-2800a sn:(b)(4) was having accuracy issues.Service requested: troubleshooting/assistance.Service performed: the customer was found to be using the wrong type of nasal cannula/flow rate combination, which caused the inaccurate readings.Investigation result: the root cause was determined to be user error/education.Customer did not have the proper set up.The device was operating within specifications.The device was in use with a patient and there was no reported harm.
Additional Manufacturer Narrative
H10: additional narrative: on (b)(6) 2018, (b)(6) reported the co2 monitor olg-2800a sn:(b)(6) was having accuracy issues.Service requested: troubleshooting/assistance.Service performed: the customer was found to be using the wrong type of nasal cannula/flow rate combination, which caused the inaccurate readings.Investigation result: the root cause was determined to be user error/education.Customer did not have the proper set up.The device was operating within specifications.The device was in use with a patient and there was no reported harm.Based on the given information, this complaint record can be closed as no further investigation is needed at this time.Corrected information: g4.Date received by manufacturer: should be 06/06/2018 not 07/09/2018 as listed on mdr initial report.
Event or Problem Description
The nurse reported that the co2 monitor was delivering inaccurate readings, and that it was being caused by the high flow rate of the nasal cannula.

• Brand Name: OLG-2800A
• Common Device Name: CARBON DIOXIDE MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7671848
• Report Number: 8030229-2018-00250
• Device Sequence Number: 2771351
• Product Code: CCK
• UDI-Device Identifier: 04931921103814
• UDI-Public: 4931921103814
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K062115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2019
• Report Date (Section F): 08/01/2019

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: OLG-2800A
• Device Catalogue Number: OLG-2800A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2019
• Device Age: 63 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 03/18/2019
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 03/19/2019; 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/01/2019