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	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clinical staff swapped out the unit right away for the remainder of the case.They sent the failed unit in for repair and it is currently awaiting evaluation.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 (bme) reported that, during a case, the multigas unit had inaccurate etco2 and sevo values.It also gave a calibration error message.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2018, customer stated that device gives incorrect etco2 and sevo readings.Device gives calibration error.Customer used the same water trap and sampling on a replacement gas unit without issue.Service requested: repair.Service performed: repair.Investigation result: device was placed into service on 10/24/2012.Service history shows no other notifications.Maintenance history is unknown.Customer reused the water trap and sampling line a replacement gas unit.Nka repair center evaluated the device.The reported issue of calibration error could not be duplicated; however, the inaccurate gas readings was confirmed.After gas unit was successfully calibrated, the gas readings were still out of specification.It was recommended to replace the gas sensing unit, cd-237p.Review of the device history record (dhr) shows that the unit has no history of capa, ncmr, refurbishing, or other suspected defects correction: d4.Udi#, incorrectly listed on mdr initial.Updated on mdr follow up 001.Additional information: b4.Date of this report.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.Device evaluation.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that, during a case, the multigas unit had inaccurate etco2 and sevo values.It also gave a calibration error message.

• 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: 7871306
• Report Number: 8030229-2018-00365
• Device Sequence Number: 1703526
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/17/2019
• Report Date (Section F): 10/17/2019

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: 08/31/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2019
• Device Age: 73 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/17/2019
• 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: 10/17/2019