MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA 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 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the dryline assembly was recently changed in the multi-gas unit and it was working.Now the multi-gas unit is giving very erratic reading and then maxed out.The multi-gas unit was received by nihon kohden and evaluated.The device was tested for an extended period and consistently passed air and gas calibration.The reported issue could not be duplicated.A message was left for the biomedical engineer at the hospital advising that the reported issue could not be duplicated.Currently waiting for return call from the biomedical engineer at the hospital.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 dryline assembly was recently changed in the multi-gas unit and it was working.Now the multi-gas unit is giving very erratic reading and then maxed out.

Manufacturer Narrative

The customer reported that the dryline assembly was recently changed in the multi-gas unit and it was working.Now the multi-gas unit is giving very erratic reading and then maxed out.The multi-gas unit was received by nihon kohden and evaluated.The device was tested for an extended period and consistently passed air and gas calibration.The reported issue could not be duplicated.A message was left for the biomedical engineer at the hospital on (b)(6) 2015 and (b)(6) 2015 advising that the reported issue could not be duplicated.The biomedical engineer called nihon kohden back on (b)(6) 2015 and said it was okay to ship this device back.The device was shipped back to the customer on (b)(6) 2015.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AG-920RA
• 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: 5203374
• MDR Text Key: 30452415
• Report Number: 8030229-2015-00353
• 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: 11/04/2015,10/05/2015

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?: Yes
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2015
• Distributor Facility Aware Date: 10/05/2015
• Device Age: 50 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2015
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2011
• 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