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

Model Number	AG-920RA
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multi-gas unit is not giving accurate gas readings.No consequence or impact to the patient was reported.The reported device was returned to nihon kohden; however, device evaluation anticipated, but not yet begun.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 customer reported that the multi-gas unit is not giving accurate gas readings.No consequence or impact to the patient.
Additional Manufacturer Narrative
The multigas unit was sent in for evaluation.Nihon kohden's repair center noted that the multigas unit came in with a damaged water trap.When used with a working water trap, the multigas unit gave accurate readings.No issues were found when tested with this setup.Thus, it is concluded that the damaged water trap may have caused the reported inaccuracy issue.This multigas unit was put into service on 8/18/2012, and the warranty expired on 8/18/2017.Nihon kohden was unable to perform the repairs due to a lack of available parts and the customer agreed to have the unit sent back without the repairs being performed.The service history shows no other tickets created under this serial number.
Additional Manufacturer Narrative
H10: additional narrative: customer stated multi gas unit is not giving accurate gas readings.Customer had replaced all tubing, water trap, and calibrated unit.After the said maintenance, the unit would work for about a week and then gas readings will become extremely inaccurate.Service requested: repair.Service performed: repair.Investigation result: nka repair center evaluated the gas unit.It was noted that the gas unit came in with a damaged water trap.When used with a working water trap, the gas unit gave accurate readings.No issues were found when tested with this setup.Thus, it is concluded that the damaged water trap may have caused the reported inaccuracy issue.This gas unit was put into service on 8/18/2012.Warranty expired on 8/18/2017.Service history shows no other tickets created under this serial number.Corrected information: f9.Approximate age of device: incorrectly calculated.Additional information: b4.Date of this report.D4.Unique identifier (udi) number: pre-udi requirement.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? additional information.Correction.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.
Event or Problem Description
The customer reported that the multi-gas unit is not giving accurate gas readings.No consequence or impact to the patient.

• 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: 8509494
• Report Number: 8030229-2019-00093
• Device Sequence Number: 1780667
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2019
• Report Date (Section F): 07/10/2019

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: 04/08/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/10/2019
• Device Age: 80 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019; 07/10/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/07/2019; 07/10/2019
• 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: 07/10/2019