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 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reports the multi gas unit is not producing accurate readings and is giving a "check water trap" error.The device was calibrated with calibration gas and the water trap was replaced with a new one, however, when the unit was retested with the calibration gas, incorrect numeric's were still being displayed.A loaner device was sent to the customer.The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.The "check water trap" did not reappear when a sample line was attached to it.The water trap receptacle was changed to as a precautionary measure.The device was tested with sample gas and all gases fell within service specifications.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

Event Description

The biomedical engineer reports the multi gas unit is not producing accurate readings and is giving a "check water trap" error.The unit was calibrated with calibration gas and the water trap was replaced with a new one, however, when the unit was retested with the calibration gas, incorrect numeric's were still being displayed.A loaner device was sent to the customer.

• Brand Name: GF-210RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer Contact: susan shadley ; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687133
• MDR Report Key: 5874576
• MDR Text Key: 52072552
• Report Number: 8030229-2016-00396
• 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: 08/13/2016,07/14/2016

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: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2016
• Distributor Facility Aware Date: 07/14/2016
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2016
• Initial Date Manufacturer Received: 08/13/2016
• Initial Date FDA Received: 08/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• 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