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	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were no calibration errors.The dry line/water trap was changed out and the unit was allowed to warm for at least 1 hour.The customer didn't know if nihon kohden lines were in use, but they are the same lines they have always used with no issues.The interface cable was tested and found to be fine.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.(b)(4).
Event or Problem Description
The biomedical engineer (bme) reported that the multi-gas unit gave inaccurate co2 baseline readings.Co2 was way above 0, about 4%.It looked like a band of interference at the bottom of the waveform.
Additional Manufacturer Narrative
H10: additional narrative: on (b)(6) 2019 customer reported co2 reading was above the zero baseline for this gas unit.Customer stated there was no calibration errors.Gas unit was allowed to warm for at least one hour.Customer had replaced dryline and water trap.Service requested: repair.Service performed: repair.Investigation result: nka repair center evaluated the device.It was noted that device has physical damage to the exhaust connector, the ac power source, and the ground connector.Device took approximately 45 minutes to warm up (longer than the expected time of maximum 10 minutes per service manual).Device also caused a humming noise.The reported issue of baseline being above zero was duplicated.Device was put into service on 7/20/2011.Service history shows no previous incidents.Maintenance information is not available, particularly as described under service manual for ag920r, revision e, section 5.Due to physical damage and incomplete maintenance information, the root cause could not be determined.Corrected information: g4.Date received by manufacturer: should be 05/21/2019 not 06/13/2019 as listed on mdr initial report.
Event or Problem Description
The biomedical engineer (bme) reported that the multi-gas unit gave inaccurate co2 baseline readings.Co2 was way above 0, about 4%.It looked like a band of interference at the bottom of the waveform.

• 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: 8697757
• Report Number: 8030229-2019-00219
• Device Sequence Number: 11220413
• 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: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019
• Report Date (Section F): 08/21/2019

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: 06/13/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/20/2019
• Device Age: 102 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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: 08/21/2019