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

Model Number AG-920RA

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

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

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reports that the multi gas unit looses pressure (readings) when in the middle of a case.The anesthesiologist states this has happened more than once.Loaner device was sent to the customer.The device related to this complaint was returned and evaluated.No malfunction was found.This unit was tested and passed both the zero calibration and gas calibration.All of the gases fall within the service manual specifications.

Event Description

The biomedical engineer reports that the multi gas unit looses pressure (readings) when in the middle of a case.The anesthesiologist states this has happened more than once.

Manufacturer Narrative

Manufacturer narrative: the biomedical engineer reports that the multi gas unit looses pressure (readings) when in the middle of a case.The anesthesiologist states this has happened more than once.Loaner device was sent to the customer.Attempts have been made to obtain the product.The unit was evaluated and the reported problem could not be duplicated.The unit was tested and passed both the zero cal and gas calibration.All of the gases fall within the service manual specs.The unit was returned to the customer with no repair needed.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 CORPORATION; 1-31-4 nishiochiai, shinjuku-k; attn: shama mooman; gunma 161-8 560; JA 161-8560
• 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: 5596117
• MDR Text Key: 43278401
• Report Number: 8030229-2016-00167
• 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: 04/21/2016,03/24/2016

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: 04/16/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2016
• Distributor Facility Aware Date: 03/24/2016
• Device Age: 50 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2016
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2011
• 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