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

Model Number GF-210RA

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multigas unit was not giving a reading for all gases, specifically sevoflurane.The biomed states that the unit was completely warmed up, however, was unsure when the dry line and water trap was last changed.The auxiliary cable was properly connected.Anesthesiologist believes the problem is with the gas unit and is sending the unit in for repair.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 Description

The biomedical engineer reported that the multigas unit was not giving a reading for all gases, specifically sevoflurane.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018 customer stated that gas unit was not reading some gases, specifically sevoflurane.Device was sent to nka for evaluation and repair.On 8/16/2018.Nka repair center evaluated the device.The reported issue of intermittent readings was confirmed.When re-evaluated on 1/16/2020, it was noted that device was displaying "device error".Service requested: evaluation/repair.Service performed: evaluation.Investigation result: customer did not know when the sampling line and watertrap were last replaced.Sampling lines are single-use, disposable units.Watertrap is to be replaced at approximately 40 hours of use (one week) or when the error message "check watertrap" appears.Device was put into service on 4/30/2016.Service history shows this is an isolated service incident.Information necessary for investigation was not available, specifically: water trap replacement frequency.Gas settings on bedside monitor.For example, if the screen layout on the bedside monitor is set to fixed mode, are the parameter settings properly configured? verification of proper connection for the water trap and sampling line.Are the gas units positioned at a permanent location or frequently moved? if frequently moved, is the multi-link connection cable next to the grounding terminal securely seated with two screws tightened? are there any bents on the exhaust gas tube? does the bacterial filter, where the exhaust tube is connected to, conform to 0.2 micrometer pore size? are the units stored in high humidity locations? is there adequate space behind the unit for the fan to operate properly? are there any units placed vertically? if so, did customer orientate the water trap according to manual's instruction? service manual for gf-210r/220r, second edition, printed 2012/09/21 includes the following selected items: general handling precautions: instrument must receive expert, professional attention for maintenance and repairs.When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order.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.Per service manual, regular maintenance and inspection must be performed every six months.Zero calibration: in order to compensate for zero-point drift, the unit periodically takes in ambient air and performs an automatic zero calibration (auto zero calibration).Zero calibration finishes within 60 seconds.Auto zero calibration interval is as follows: · when unit is in steady state - auto zeroes every 2 hours if auto zero calibration fails, perform a manual zero calibration.For calibration procedures, refer to operator's manual or service manual of the connected beside monitor.Based on the troubleshooting section: anesthesia gas problems of the service manual, 2nd edition, the reported issue is diagnosed as sensor failure.Various factors could affect the performance of the device.With little information provided regarding customer's maintenance of the device, the root cause of the sensor failure could not be determined.A review of manufacturer's device history record shows no nonconforming report, no deviation and no corrective and preventative actions associated with this device.Investigation conclusion: based on the troubleshooting section: anesthesia gas problems of the service manual, 2nd edition, the reported issue is diagnosed as sensor failure.Various factors could affect the performance of the device.With little information provided regarding customer's maintenance of the device, the root cause of the sensor failure could not be determined.

Event Description

The biomedical engineer reported that the multigas unit was not giving a reading for all gases, specifically cevoflurane.

• Brand Name: GF-210RA
• Type of Device: 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: 7546761
• MDR Text Key: 109361146
• Report Number: 8030229-2018-00174
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 4931921106891
• Combination Product (y/n): N
• PMA/PMN Number: K110594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

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
• Device Operator: Health Professional
• Device Model Number: GF-210RA
• Device Catalogue Number: GF-210RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2020
• Distributor Facility Aware Date: 01/16/2020
• Device Age: 33 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1