MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GF-210RA; MULTI-GAS UNIT

Model Number	GF-210RA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the co2 and sevoflurane readings weren't correct on the multigas unit and no further information was provided to them by the staff.When the biomed checked the unit with their calibration canister, they found the values were out of range.They feel that the unit needs to be calibrated and are unable to do this on this model.The biomed believes this happened during a procedure.No patient harm 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.Concomitant medical device information: bedside monitor bsm-6501a, sn (b)(4).
Event or Problem Description
The biomedical engineer reported that the co2 and sevoflurane readings weren't correct on the multigas unit and no further information was provided to them by the staff.The biomed believes this happened during a procedure.No patient harm reported.
Event or Problem Description
The biomedical engineer reported that the co2 and sevoflurane readings weren't correct on the multigas unit and no further information was provided to them by the staff.The biomed believes this happened during a procedure.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2019, the customer called nk tech support stating that the multigas unit (gf-210ra) was giving a "calibration needed" reading.The caller was in the purchasing department and did not have additional details.On (b)(6) 2019, the biomed stated that the clinical staff reported to him that co2 and sevoflurane readings were not correct but did not give further details.When the biomed checked the unit with the calibration canister, the values were out of range.The biomed confirmed the no "calibration needed" messages were reported.The device was not sent to nka under this complaint.Service requested / performed: exchange.Investigation summary: the overall risk score is medium.The issue was determined to be sensor related.The root cause is determined to be component failure: a sensor needed to be replaced.The sensor is a replaceable component, where the longevity is dependent upon the following factors: instrument and parts must undergo regular maintenance inspection at least every 6 months.If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.Water trap should be replaced every 4 weeks or as indicated on the device.Ensure the environment is optimal as described in the operator's manual.Based on sop07-003, no capa is required as the quality event does not warrant a corrective action.The following fields are not applicable (na) to the mdr report: d4 lot # & expiration date g4 device bla number the following fields contain no information (ni), as attempts to obtain information were made, but not provided: additional device information: d10 concomitant medical device: the following device was used in conjunction with the multigas unit: bsm: model #: bsm-6501a serial #: (b)(6) additional information: b4 date of this report d9 device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• Brand Name: GF-210RA
• Common Device Name: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 8881107
• Report Number: 8030229-2019-00360
• Device Sequence Number: 2128145
• Product Code: CCK
• UDI-Device Identifier: 04931921115305
• UDI-Public: 04931921115305
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021
• Report Date (Section F): 08/09/2019

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: GF-210RA
• Device Catalogue Number: GF-210RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/18/2019
• Device Age: 31 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BSM-6501A SN (B)(6); BSM-6501A SN (B)(6)
• Date Report Sent to FDA: 08/09/2019