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

Model Number GF-210RA

Device Problems Gas Output Problem (1266); No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit (gf-210ra) failed during use on a patient.The device gave a "gas external device failure" error message across the top of the bedside (bsm).No consequence or impact to the patient was reported.The device has been returned to nihon kohden and is 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.The following device was used in conjunction with the multigas unit and was not the device that experienced the failure.Concomitant medical device: bsm: no model or serial number was provided.

Event Description

The customer reported that the multigas unit (gf-210ra) failed during use on a patient.The device gave a "gas external device failure" error message across the top of the bedside (bsm).No consequence or impact to the patient was reported.

Manufacturer Narrative

Details of complaint: on 10/10/19, customer at ssm depaul health center reported the multigas unit (gf-210ra sn: (b)(6) was not providing end tidal co2 (etco2) readings.The device was giving a "gas external device failure" error.Service requested/service performed: nka repair center evaluation: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.Physical evaluation: no physical damage nor fluid intrusion.Verify the complaint: duplicated gas device error.Investigation conclusion: the root cause of the cd-314p failure could not be determined from the information available.Manufacturer's investigation concluded no tendency of cd-314p-01 failure.The recommended action by nkc is to replace the gas sensor unit.Tracking and trending will be conducted during quarterly qa review.Additional device information: the following device was used in conjunction with the multigas unit and was not the device that experienced the failure.D11 & c2 concomitant medical device: bsm: no model or serial number was provided.

Event Description

The customer reported that the multigas unit (gf-210ra) failed during use on a patient.The device gave a "gas external device failure" error message across the top of the bedside (bsm).No consequence or impact to the patient was reported.

• 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: 9269238
• MDR Text Key: 200634450
• Report Number: 8030229-2019-00615
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2020
• Distributor Facility Aware Date: 03/12/2020
• Device Age: 32 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2020
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BSM; BSM