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

Model Number	GF-210RA
Medical Device Problem Codes	Unable to Obtain Readings (1516); Communication or Transmission Problem (2896); Output Problem (3005); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the multigas unit gave a "device error" message.The biomedical engineer has tried different cables and monitors that are known to work, but the problem still persists.No patient harm or injury was reported.The customer sent the device in for evaluation.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a bsm device was used in conjunction with the multigas unit, but did not experience failure.Attempts to obtain the following information were made, but not provided: bsm - model: ni, s/n: ni, approximate age of the device: no serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.
Event or Problem Description
The biomedical engineer reported that the multigas unit gave a "device error" message.
Additional Manufacturer Narrative
Details of complaint: customer reported that the multigas unit was causing a "device error" message on the connected bedside monitor.The device was sent to nka for evaluation and repair.No patient harm was reported.Service requested / performed: exchange / evaluation: nka's repair center evaluated the device.A "device error" was noted.The issue was determined to be sensor related.Investigation summary: the overall risk score is medium.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.
Event or Problem Description
The biomedical engineer reported that the multigas unit gave a "device error" message.

• 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: 8947877
• Report Number: 8030229-2019-00419
• Device Sequence Number: 226714
• Product Code: CCK
• UDI-Device Identifier: 00841983100321
• UDI-Public: 00841983100321
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021
• Report Date (Section F): 08/29/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2019
• Device Age: 66 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 08/17/2021
• 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; BSM
• Date Report Sent to FDA: 08/29/2019