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

Catalog Number KNCF476-6121Z

Device Problem Disconnection (1171)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/13/2012

Event Type  malfunction  

Event Description

Anesthesiologist noted co2 levels were not normal during anesthesia.Another anesthesia machine was used but did not correct the issue.It was noticed that the inner tube of the coaxial circuit had disconnected from the connector.The anesthesia circuit was replaced and the issue resolved.The case was delayed as a result.

• 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: 4012371
• MDR Text Key: 17297260
• Report Number: 1824226-2014-00007
• Device Sequence Number: 1
• Product Code: OFP
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/19/2014

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KNCF476-6121Z
• Device Lot Number: IZDZ5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2012
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other