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

Model Number GF-210RA

Device Problems Failure to Sense (1559); Device Stops Intermittently (1599)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit had no end tidal co2 readings.Nihon kohden's technical services advised that the correct cable was not in use.The unit constantly tried to recalibrate causing the waveforms to flat-line then disappear.Clearing the water trap helped, but the unit worked only intermittently.The unit was in use on a patient, but no patient harm was reported.The customer sent the unit in and it is currently awaiting evaluation.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 had no end tidal co2 readings.

Manufacturer Narrative

The customer reported that the multi gas unit had no end tidal co2 readings.Nihon kohden's technical services advised that the correct cable was not in use.The unit constantly tried to recalibrate causing waveforms to flat-line then disappear.Clearing the water trap helped, but the unit worked only intermittently.The unit was in use on a patient, but no patient harm was reported.The customer sent the unit in and the unit was evaluated by nihon kohden.After extended testing was performed, the reported problem of "intermittent issues with showing entidal co2" was not duplicated, however the gas unit was replaced for precautionary measure.The unit was tested per operator's/service manual and the unit completed 24 hours of extended testing and operates to manufacturer's specifications.

• 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, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; 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 ; 2687488
• MDR Report Key: 6632455
• MDR Text Key: 77317966
• Report Number: 8030229-2017-00190
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 4931921106891
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• 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: 06/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/09/2017
• Distributor Facility Aware Date: 05/16/2017
• Device Age: 44 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2017
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2013
• 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