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

Model Number GF-210RA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit stopped giving gas readings.He sent the unit in for repair and it is currently awaiting evaluation.The device was in use on a patient, however no patient harm was 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.

Event Description

The customer reported that the multigas unit stopped giving gas readings.

Event Description

The customer reported that the multigas unit stopped giving gas readings.

Manufacturer Narrative

Details of complaint: on 11/17/2017, the customer at mercy health reported the following issue with gf-210ra; sn (b)(4), from patient monitoring: unit warms up for over an hour and gives a reading for a few minutes, then just stops working.When the gas unit was moved to another bsm, the issue followed.Customer would like to send the unit in for repair.Service requested: exchange.Service performed: on (b)(4) 2018 the unit was cleaned and evaluated.The reported problem could not be duplicated, however the repair center evaluation found that the unit could not detect if a water trap was present or not.All malfunctioning parts were replaced: cd-314p gas unit.The unit was tested per operator's/service manual and completed 48 hours of extended testing.The unit operates to manufacturer's specifications.Repair was completed and the unit was shipped back to the customer on (b)(4) 2018.No issues have been reported since then.Investigation summary: the root cause of the issue could not be determined due to the repair center's inability to duplicate the issue on evaluation.The overall risk of this event, taking into consideration of severity and probability, is "high".

• 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: 7123762
• MDR Text Key: 95078373
• Report Number: 8030229-2017-00430
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• 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: 11/30/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2020
• Distributor Facility Aware Date: 06/22/2020
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2020
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1