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 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the "gas analyzer had a 'line blocked' error." the customer checked the sample line and water trap and both were in good condition.The multigas unit was losing waveform on the monitor.After reseating the water trap and sample line the waveforms came back.However, the customer states that the numeric values dropped with waveform.The device was returned to nihon kohden, evaluated, and the reported issue could not be duplicated.This unit was tested for an extended period and the 'line blocked' error was never seen.The water trap that was sent with this unit was used as well as the sample line.This unit passes air calibration and all gases read within service manual specifications.The customer was notified of the evaluation and the multi-gas unit was returned to the customer.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 the "gas analyzer had a 'line blocked' error." the customer checked the sample line and water trap and both were in good condition.The multigas unit was losing waveform on the monitor.After reseating the water trap and sample line the waveforms came back.However, the customer states that the numeric values dropped with waveform.

• 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: 5435614
• MDR Text Key: 38218936
• Report Number: 8030229-2016-00057
• 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: 02/12/2016,01/13/2016

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: 01/22/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2016
• Distributor Facility Aware Date: 01/13/2016
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2016
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• 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