MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION AG-920RA; MULTI-GAS UNIT

Model Number	AG-920RA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was advised to replace the dryline receptacle to resolve the issue.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 biomedical engineer (bme) reported that the multigas unit gave inaccurate readings.
Event or Problem Description
The biomedical engineer (bme) reported that the multigas unit gave inaccurate readings.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2018 customer reported gas unit was providing inaccurate gas readings when patient was on gas agents.Gas readings were accurate when patient was not on treatment.When nk tech support followed up on the issue, customer responded on 3/26/2019 stating the device was shortly decommissioned and replaced by the newer model gf-210ra.Customer no longer uses ag-920ra s/n (b)(6).Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: device was put into service on 3/3/2011.Service history shows no other service notifications for this device.Ag-920ra operator's manual revision j stated that gas calibration should be performed yearly for stable measuring accuracy.When the accuracy is not appropriate, perform gas calibration.The maintenance history for this device is unknown.Review of the device history record (dhr) shows that the unit has no history of ncmr, refurbishing, or other suspected defects (see attached).Due to limited information provided by customer, the root cause of the reported issue could not be determined.Investigation conclusion: due to limited information provided by customer, the root cause of the reported issue could not be determined.

• Brand Name: AG-920RA
• Common Device Name: MULTI-GAS UNIT
• 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: 7871301
• Report Number: 8030229-2018-00362
• Device Sequence Number: 13944149
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K020046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020
• Report Date (Section F): 01/10/2020

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: AG-920RA
• Device Catalogue Number: AG-920RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/08/2020
• Device Age: 94 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 01/10/2020
• 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: 01/10/2020