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

Model Number AG-920RA

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multi-gas unit stopped working, sensor calibration error carbon-dioxide.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 stopped working, sensor calibration error carbon-dioxide.

Manufacturer Narrative

Manufacturer narrative: the customer reported that the multi-gas unit stopped working, sensor calibration error carbon-dioxide.The unit was cleaned and evaluated.The reported problem of intermittent cal error was duplicated.The gas sensing unit was replaced to resolve the issue.The device has been repaired and returned 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 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: 6012556
• MDR Text Key: 57317075
• Report Number: 8030229-2016-00510
• 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: 10/07/2016,09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• 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: 09/17/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2016
• Distributor Facility Aware Date: 09/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2016
• Date Manufacturer Received: 10/07/2016
• 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