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	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported problem "gas sensor unit is not giving accurate gas readings" was duplicated.Nihon kohden's repair center powered on and connected the gas unit to the bedside monitor (bsm) for testing.It was determined that the gas sensor unit should be replaced to resolve the issue.Once a po for this repair has been received by nihon kohden, the repair will be performed.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 the multigas unit was giving inaccurate readings.
Additional Manufacturer Narrative
Details of complaint: on 10/10/2018.Customer stated this gas unit was not giving accurate readings.Customer had yet to calibrate the unit.Water trap, and tubing were replaced as well as ensuring aux cable was connected.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: operator's manual revision j stated that gas calibration should be performed yearly for stable measuring accuracy.When the accuracy is not appropriate, perform gas calibration.The maintenance history for this device is unknown.Nka repair center evaluated the device and recommended replacing cd-237p gas unit sensor to resolve the issue.When repair services completed replacing the sensor, the issue was resolved.This was confirmed through 2 days of extended testing.Device operated to manufacturer's specification.Device was put into service on 8/4/2011.Warranty expired on 8/4/2016.Gas sensor failed after 98 months of service.Service history for this device shows no other notifications.Due to limited information available regarding the maintenance of the device, the root cause could not be determined.Corrected data: udi # incorrectly listed.No udi , pre-udi requirement.
Event or Problem Description
The biomedical engineer (bme) reported that the multigas unit was giving inaccurate readings.

• 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: 8053497
• Report Number: 8030229-2018-00428
• Device Sequence Number: 1484567
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K020046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019
• Report Date (Section F): 10/21/2019

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: 11/01/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2019
• Device Age: 94 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 10/21/2019
• 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: 10/21/2019