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

Model Number GF-210RA

Device Problems Image Display Error/Artifact (1304); Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multigas unit was giving a "device error" message.They would like to have the unit warranty replaced.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 when additional information becomes available.

Event Description

The biomedical engineer (bme) reported that the multigas unit was giving a "device error" message.No patient harm was reported.

Manufacturer Narrative

Details of complaint: on (b)(6) 2020, customer at (b)(6) health shared service reported the multigas unit (gf-210ra sn: (b)(6) ) displayed a device error while in us on a patient.Service requested: exchange.Service performed: the unit was returned and evaluated at nka: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified physical evaluation: no physical damage to report verify the complaint: customer state that unit gets a device error.Unable to duplicate the issue.Unit had burned in 24 hours test without any issue.The unit was cleaned, evaluated, and tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 24 hours of extended testing and operates to manufacturer's specification.Investigation summary: the root cause is not known as evaluation of the unit did not confirm the customer reported issue.Details on how the instrument was set up and used at the time of reported issue was not provided.The reported issue does not require further investigation through the capa process.Investigation determined the issue poses medium risk.

Event Description

The biomedical engineer (bme) reported that the multigas unit was giving a "device error" message.No patient harm was reported.

• Brand Name: GF-210RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia; attn: shama mooman; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 10417831
• MDR Text Key: 203858592
• Report Number: 8030229-2020-00459
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/17/2020,04/23/2021

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2020
• Distributor Facility Aware Date: 07/20/2020
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1