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

Model Number GF-210RA

Device Problem Output Problem (3005)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

The customer reported that they're barely getting any co2 reading on the multigas unit.There was no patient injury reported.

Manufacturer Narrative

The customer reported that they're barely getting any co2 reading on the multigas unit.According to the customer, they had to "scale" it up a ton to be able to see anything.The customer is no longer able to read co2 monitoring data.Technical support (ts) advised the customer to exchanged the unit as it cannot be repaired.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 they're barely getting any co2 reading on the multigas unit.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that they're barely getting any co2 reading on the multigas unit.According to the customer, they had to "scale" it up a ton to be able to see anything.The customer is no longer able to read co2 monitoring data.Technical support (ts) advised the customer to exchanged the unit as it cannot be repaired.There was no patient injury reported.Investigation summary: the root cause is determined to be component failure: sensor needed replacement.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.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: 14017626
• MDR Text Key: 289024210
• Report Number: 8030229-2022-02699
• 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: 03/08/2023

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: 03/07/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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
• Treatment: NI.; NI.