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

Model Number GF-210RA

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit displayed an external gas device error randomly.According to the customer, the error is not being displayed now; however, when it is displayed, the only way to get rid of it is by rebooting the unit.They experience this error before each case.The customer requested that the unit be exchanged.There was no patient injury 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 customer reported that the multigas unit displayed an external gas device error randomly.There was no patient injury reported.

Event Description

The customer reported that the multigas unit displayed an external gas device error randomly.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the multigas unit displayed an external gas device error randomly.According to the customer, the error is not being displayed now; however, when it is displayed, the only way to get rid of it is by rebooting the unit.They experience this error before each case.The customer requested that the unit be exchanged.There was no patient injury reported.Investigation summary: the error corresponds to a failure of the sensor unit - cd-314p.The unit was determined to be sensor related.The root cause is determined to be component failure.The sensor is a replaceable component, where the longevity is dependent upon the following factors: · 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.· water trap should be replaced every 4 weeks or as indicated on the device.· ensuring the environment is optimal as described in the operator's manual.The reported issue was duplicated.Sensor cd-314p was replaced to resolve the issue.Manufacturer references # (b)(4) follow up 001.

• Brand Name: GF-210RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13772232
• MDR Text Key: 289358818
• Report Number: 8030229-2022-02622
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 04931921106891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1