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

Model Number GF-210RA

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reports that the device was getting a "water trap error".The water trap was changed, which did not resolve the issue.Biomedical engineer was sent the direction for changing the water trap.Biomedical engineer reports that the gas readings are intermittently dropping.Unit is being sent in for repair.Loaner was sent to customer.The unit was returned and evaluated.The issue could not be duplicated.The unit was tested for an extended period and all gases fell within the manual specs.The "check water trap" message appears anytime this model of gas unit has the sample line removed.Once the sample line is reattached this message goes away.

Event Description

The biomedical engineer reports that the device was getting a "water trap error".The water trap was changed, which did not resolve the issue.Biomedical engineer was sent the direction for changing the water trap.Biomedical engineer reports that the gas readings are intermittently dropping.

• Brand Name: GF-210RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer Contact: thomas bento ; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687708
• MDR Report Key: 5679447
• MDR Text Key: 45920569
• Report Number: 8030229-2016-00206
• Device Sequence Number: 1
• Product Code: CCK
• 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
• Report Date: 05/25/2016,04/26/2016

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
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2016
• Distributor Facility Aware Date: 04/26/2016
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2016
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2014
• 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