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

Model Number AG-920RA

Device Problem Calibration Error (1078)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2015

Event Type  malfunction  

Event Description

The customer stated that the ag-920pa multi-gas unit (used for measurement of anesthetic gas agents, oxygen, or co2) reported a calibration error.

• Brand Name: AG-920RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN CORP.
• Manufacturer (Section G): NIHON KOHDEN AMERICA, INC.; 90 icon st.; foothill ranch CA 92610 160
• Manufacturer Contact: 90 icon st.; foothill ranch, CA 92610-1601
• MDR Report Key: 4949350
• MDR Text Key: 6036275
• Report Number: 2080783-2015-00185
• Device Sequence Number: 1
• Product Code: CCK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/30/2015

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2015
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1