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 06/23/2022

Event Type  malfunction  

Event Description

The biomedical engineer reported that they were having issue with the multigas unit intermittently producing readings.Then it completely stopped producing readings / waveforms.Then it came back about 5 minutes later and then dropped off again.The cable was connected to the unit correctly.It is unclear whether there was an error message displayed when the failure occurred.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer reported that they were having issue with the multigas unit intermittently producing readings.Then it completely stopped producing readings / waveforms.Then it came back about 5 minutes later and then dropped off again.The cable was connected to the unit correctly.It is unclear whether there was an error message displayed when the failure occurred.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.Attempt #1 06/27/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 07/11/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 07/12/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: concomitant medical products: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.

Manufacturer Narrative

Details of the complaint: the biomedical engineer reported that they were having issue with the multigas unit intermittently producing readings.Then it completely stopped producing readings / waveforms.Then it came back about 5 minutes later and then dropped off again.The cable was connected to the unit correctly.It is unclear whether there was an error message displayed when the failure occurred.No patient harm was reported.Investigation conclusion: based on the operator's manual, known causes for no readings are related to incorrect settings or use error.The customer's complaint history suggests that the facility has a history of having intermittent readings due to improper use of the gf-201ra device.The customer has a history of using non specified components to be used with the gf-210ra.Root cause is likely related to use error.This issue will be trended as additional education may be necessary should this issue recur with the exchange device.Attempt #1 06/27/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 07/11/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 07/12/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The biomedical engineer reported that they were having issue with the multigas unit intermittently producing readings.Then it completely stopped producing readings / waveforms.Then it came back about 5 minutes later and then dropped off again.The cable was connected to the unit correctly.It is unclear whether there was an error message displayed when the failure occurred.No patient harm was reported.

• 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: 15061434
• MDR Text Key: 304127941
• Report Number: 8030229-2022-03017
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• 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: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2022
• 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