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

Catalog Number KNCF370-6121Z

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2011

Event Type  malfunction  

Event Description

Inner tube of coaxial breathing circuit disconnected prior to use.

• Brand Name: UNIVERSAL FLEX2 CIRCUIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; noblesville IN
• Manufacturer Contact: 15011 herriman blvd.; noblesville, IN 46060 ; 3177766823
• MDR Report Key: 4012576
• MDR Text Key: 18871113
• Report Number: 1824226-2014-00004
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2014

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: KNCF370-6121Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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