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	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multi-gas unit gave inaccurate co2 readings.No patient harm reported.The customer indicated that this unit would work and gave accurate readings for about 30 minutes, but then the co2 readings would start to get erratic and incorrect.He replaced the sampling line and water trap on the unit, but it still gave incorrect readings.The customer then tried to calibrate the unit, but the device displayed a "cal error" and he was unable to successfully calibrate the gas unit.The customer sent the unit in and it is currently awaiting evaluation.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 multi-gas unit gave inaccurate co2 readings.No patient harm reported.
Additional Manufacturer Narrative
Details of the complaint: on 10/16/19, customer at (b)(6) health center reported the gas unit (ag-920ra sn: (b)(6)) was receiving an error when they were trying to calibrate it.The co2 readings were also reported to be inaccurate.Service requested: repair.Service performed: physical evaluation: the unit was cleaned and decontaminated.The model, serial number and all labels were verified.No physical damage.Verify the complaint: cal error message.Problem cannot be duplicated.The unit operated well at this time, running quietly, there is no humming noise.After being notified of cnd status, customer wanted to have this unit repaired.The part was replaced.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.Investigation conclusion: as the reported issue could not be reproduced at nka, the root cause could not be determined.Risk analysis was not conducted as evaluation of the unit at nka did not identify a non-conformance.The following fields are not applicable (na) to the mdr report: d4 lot number & expiration date.Additional information: b4.Date of this report.D10: device available for evaluation? f6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? h3: device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.
Event or Problem Description
The customer reported that the multi-gas unit gave inaccurate co2 readings.No patient harm reported.

• 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: 9300111
• Report Number: 8030229-2019-00636
• Device Sequence Number: 13986058
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020
• Report Date (Section F): 03/04/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/03/2020
• Device Age: 86 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/04/2020