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

Model Number GF-210RA

Device Problem Output Problem (3005)

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

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit is displaying an "external device" error message.No harm or injury was reported.The customer will be sending the failed unit in for an exchange.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 fields contain no information (ni), as attempts to obtain information were made, but not provided: concomitant medical products.

Event Description

The customer reported that the multigas unit is displaying an "external device" error message.

Manufacturer Narrative

Details of complaint: on (b)(6) 2020 customer stated gas unit did not gives "external device failure" on the host monitor.The failure is related to gas sensor.Investigation summary the root cause of reported issue was determined to be firmware related.An update is required to correct this issue.Capa (b)(4) has been initiated.

Event Description

The customer reported that the multigas unit is displaying an "external device" error message.

• 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: 10350555
• MDR Text Key: 201572470
• Report Number: 8030229-2020-00422
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 04931921106891
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: 07/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Distributor Facility Aware Date: 08/07/2020
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2020
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1