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 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multi-gas unit is giving a calibration error when running on gas and air cal.Multiple attempts to calibrate the unit failed each test.Additionally, the biomedical engineer would get an out of range error when running the air cal intermittently.The device was returned to nihon kohden, evaluated, and the reported issue was not able to be confirmed or duplicated.The device passed all air and gas calibrations.The device was run for 48 hours and then an air and gas calibration was performed per additional customer request.The device passed the air and gas calibrations.It was decided that the gas sensing unit would be replaced as a precautionary measure.The device was retested after the replacement to ensure it functioned correctly.The unit passed the air and gas calibration.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the multi-gas unit is giving a calibration error when running on gas and air cal.Multiple attempts to calibrate the unit failed each test.Additionally, the biomedical engineer would get an out of range error when running the air cal intermittently.

• 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: 5171756
• MDR Text Key: 29212234
• Report Number: 8030229-2015-00315
• 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
• Report Date: 10/22/2015,09/22/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2015
• Distributor Facility Aware Date: 09/22/2015
• Device Age: 50 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2015
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 10/23/2015
• 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