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.The o2 reading is coming in at half the value it should be.The biomedical engineer has replaced the dryline and the issue still persists.The device was returned to nihon (b)(4), evaluated, and the calibration error was duplicated.The device was disassembled and the internal gas was replaced to fix this issues.Gases are in specifications in regards to the service/operators manual.All functions were tested prior to shipment.The device was returned to the customer.Nihon (b)(4) will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

Event Description

The customer reported that the multi-gas unit is giving a calibration error.The o2 reading is coming in at half the value it should be.The biomedical engineer has replaced the dryline and the issue still persists.

• 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: 5171766
• MDR Text Key: 29193697
• Report Number: 8030229-2015-00317
• 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