MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORP. AG-920RA; MULTI-GAS UNIT

Device Problem Calibration Error (1078)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Please refer to (b)(4).

Manufacturer Narrative

There was no injury or adverse event.Evaluated ag-920ra.Duplicated calibration error.The gas unit will need to be replaced to fix this issue.Once it is replaced the unit will be returned to the customer.

Manufacturer Narrative

The unit was repaired and returned to the customer.

• Brand Name: AG-920RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORP.
• Manufacturer Contact: 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8-560 ; 2687708
• MDR Report Key: 4949336
• MDR Text Key: 6633400
• Report Number: 8030229-2015-00185
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• PMA/PMN Number: K020046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1