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

Model Number AG-920RA

Device Problems Calibration Error (1078); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the gas reading on the multi gas unit is inaccurate.When trying to calibrate the unit, a "cal error" message was displayed.The water trap and dryline were replaced, however the issue remained the same.The device was returned to nihon kohden, evaluated, and the reported issue was not able to be confirmed.The customer requested we replace the gas sensing unit on this device which was done.The device was tested per the operator's / service manual.The device was tested and operates to manufacturer's specifications.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 reports that the gas reading on the multi gas unit is inaccurate.When trying to calibrate the unit, a "cal error" message was displayed.The water trap and dryline were replaced, however the issue remained the same.

Manufacturer Narrative

Manufacturer narrative: the customer reports that the gas reading on the multi gas unit is inaccurate.When trying to calibrate the unit, a "cal error" message was displayed.The water trap and dryline were replaced, however the issue remained the same.The device was returned to nihon kohden, evaluated, and the reported issue was not able to be confirmed.The customer requested we replace the gas sensing unit on this device which was done.The device was tested per the operator's / service manual.The device was tested and operates to manufacturer's specifications.The unit has been prepared and returned.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• 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 mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 6046211
• MDR Text Key: 58021091
• Report Number: 8030229-2016-00520
• 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: 10/20/2016,09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• 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: 10/11/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2016
• Distributor Facility Aware Date: 09/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2016
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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