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

Model Number AG-920RA

Device Problems False Reading From Device Non-Compliance (1228); Device Inoperable (1663); Failure to Calibrate (2440)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multi-gas unit will not calibrate and the numbers it gives are not correct.The device was returned to nihon kohden, however it has not yet been evaluated.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 reported that the multi-gas unit will not calibrate and the numbers it gives are not correct.

Manufacturer Narrative

Corrected data: device evaluated by manufacturer.Additional manufacturer narrative: the customer's complaint was confirmed.The gas sensing unit was replaced and the unit was calibrated and tested prior to shipping back to the customer.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 TOMIOKA CORPORATION; 1-1 tajino; attn; susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer Contact: susan shadley ; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687133
• MDR Report Key: 5540659
• MDR Text Key: 42031821
• Report Number: 8030229-2016-00132
• 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: 03/31/2016,03/01/2016

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: 03/23/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2016
• Distributor Facility Aware Date: 03/01/2016
• Device Age: 57 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2016
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2011
• 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