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	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multigas unit gave a "gas cal" error message during a case.The customer also reported that the unit is displaying low readings.They tried replacing the water trap, but the issue persisted.No patient harm or injury was reported.The customer would like to send the unit in for a repair.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.
Event or Problem Description
The customer reported that the multigas unit gave a "gas cal" error message during a case.
Event or Problem Description
The customer reported that the multigas unit gave a "gas cal" error message during a case.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the multigas unit gave a gas "cal" error message during a case.The customer also reported that the unit is displaying inaccurate readings.They tried replacing the water trap, but the issue persisted.No patient harm or injury was reported.The customer requested to send the unit in for a repair.Service requested / performed: evaluation / repair: on 12/23/2019, the reported problem could not be duplicated.The unit operated well, although, there was a constant loud humming noise that indicated the gas module would deteriorate soon.On 01/27/2020, the following malfunctioning part was replaced as a precautionary measure: gas module (part # cd-237p).The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 24 hours of extended testing and operated to the manufacturer's specifications.The repaired unit was shipped back to the customer on 01/28/2020.Investigation summary: per the operator's manual, the possible causes of the unit displaying a gas "cal" error are issues with water trap, sampling line, t-piece, or exhaust tube which need to be replaced when necessary.It could also be caused if incorrect gas was being used for calibration.The overall risk of this event is medium.The reported issue does not require further investigation through capa process since the ag-920ra is a legacy product and sales for the unit ended in 2013.Additional information: b4 date of this report d10 concomitant medical device g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• 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: 9624720
• Report Number: 8030229-2020-00044
• Device Sequence Number: 2922687
• 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): 11/15/2021
• Report Date (Section F): 01/23/2020

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/02/2020
• Device Age: 90 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSM
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/23/2020