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

Model Number	AG-920RA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multigas unit is displaying lower gas values than they should be.No errors generated.The customer tried replacing the water trap and the sample line, but the issue persisted.No harm or injury was reported.The customer will be receiving a loner device in order to mitigate this issue.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: concomitant medical products.
Event or Problem Description
The customer reported that the multigas unit is displaying lower gas values than they should be.No errors generated.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the multigas unit was displaying lower gas values than it should.No errors were generated.The customer tried replacing the water trap and the sample line, but the issue persisted.No patient harm was reported.Investigation summary: multigas units (b)(4) are in end of life (eol) / end of service.The device had been in service since 12/19/2012.A review of the history of the serial number identified no other reports against the device.Based on the available information, a definitive root cause could not be identified.Due to the age of the device, a possible cause of the issue is wear and tear of the gas sensor unit.Due to the product discontinuation, replacement parts were no longer available, and the unit could not be repaired.The issue is regarding a discontinued product, and it had likely failed due to the age and wear and tear of its gas sensor.
Event or Problem Description
The customer reported that the multigas unit was displaying lower gas values than it should.No errors were generated.

• Brand Name: AG-920RA
• Common Device Name: MULTI-GAS UNIT
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 9993183
• Report Number: 8030229-2020-00235
• Device Sequence Number: 19944121
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023
• Report Date (Section F): 04/23/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/08/2020
• Device Age: 93 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2012
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/23/2020