MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION AG-920RA; MULTI-GAS UNIT

Model Number AG-920RA

Device Problem Device Inoperable (1663)

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

Event Date 07/29/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multi-gas unit is giving a "gas line block" error after about 30 seconds of sampling.The biomedical engineer (bme) has tried a new water trap and clearing the error.The issue was noticed before the next case.The bme is going to try and clear the clog and call back if the error does not go away.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.

Event Description

The customer reported that the multi-gas unit is giving a "gas line block" error after about 30 seconds of sampling.

Manufacturer Narrative

The customer reported that the multi-gas unit is giving a "gas line block" error after about 30 seconds of sampling.The biomedical engineer (bme) has tried a new water trap and clearing the error.The issue was noticed before the next case.The bme is going to try and clear the clog and call back if the error does not go away.The defective unit was never sent in for evaluation.Due to the age of this complaint additional information necessary to conduct an investigation is not readily available.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.Device not returned.

• Brand Name: AG-920RA
• 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; gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgm; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 5920025
• MDR Text Key: 53666932
• Report Number: 8030229-2016-00430
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020046
• 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: 08/28/2016,07/29/2016

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: AG-920RA
• Device Catalogue Number: AG-920RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2016
• Distributor Facility Aware Date: 07/29/2016
• Device Age: 70 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2016
• Initial Date Manufacturer Received: 08/28/2016
• Initial Date FDA Received: 08/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2010
• 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