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	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
They sent the unit in for repair.The unit was cleaned, decontaminated, and evaluated.The reported problem could not be duplicated.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 reported that the multigas unit displayed a "select gas not specific" error message and would not display accurate co2 values.
Additional Manufacturer Narrative
The ag-920ra was evaluated by the repair center.After extended testing, the reported problem that the gas unit displayed the "select gas not specific" error message could not be duplicated.The unit was also tested against all gasses and no malfunction was found (all readings were good).The unit was processed as a "cnd" (could not duplicate), per standard operating procedures.
Additional Manufacturer Narrative
H10: additional narrative: details of complaint: on (b)(6) 2019 the customer called in to report that their ag-920ra (sn (b)(6) gas unit displays a "select gas not specific" error and will not display accurate co2 values.It was not ascertained whether the customer attempted calibration or if there was any troubleshooting.Service requested: evaluation and repair service performed device evaluation investigation report: the ag-920ra was evaluated by the repair center.After extended testing, the reported problem that the gas unit displays error "select gas not specific" could not be duplicated.The unit was also tested against all gasses and no malfunction was found (all readings were good).The unit was processed as a "cnd" (could not duplicate) and returned to customer on (b)(6) 2019.There has been no other reported incident for this device.Without additional details regarding the how user operated the device at the time of failure, the root cause could not be determined.
Event or Problem Description
The biomedical engineer reported that the the multigas unit displayed a "select gas not specific" error message and would not display accurate co2 values.

• 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: 8380512
• Report Number: 8030229-2019-00055
• Device Sequence Number: 3014234
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K020046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2019
• Report Date (Section F): 10/03/2019

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: AG-920RA
• Device Catalogue Number: AG-920RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/02/2019
• Device Age: 97 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019; 10/02/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 03/14/2019; 10/03/2019
• 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: 10/03/2019