MAUDE Adverse Event Report: KING SYSTEMS UNIVERSAL FLEX2 CIRCUIT; ANESTHESIA CIRCUIT

Catalog Number DF470-61Z

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 11/04/2011

Event Type  malfunction  

Event Description

High cardon dioxide levels.

• Brand Name: UNIVERSAL FLEX2 CIRCUIT
• Type of Device: ANESTHESIA CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; noblesville IN
• Manufacturer Contact: 15011 herriman blvd.; noblesville, IN 46060 ; 3177766823
• MDR Report Key: 4012606
• MDR Text Key: 4781333
• Report Number: 1824226-2014-00010
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DF470-61Z
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2011
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1