MAUDE Adverse Event Report: KING SYSTEMS UNIVERSAL F2 EXTENSION SET; ANESTHESIA CIRCUIT

Catalog Number XF-60

Device Problem Disconnection (1171)

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

Event Date 07/29/2013

Event Type  malfunction  

Event Description

Inner tube of coaxial breathing circuit disconnected creating high co2 levels.

• Brand Name: UNIVERSAL F2 EXTENSION SET
• Type of Device: ANESTHESIA CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; noblesville IN
• Manufacturer Contact: 15011 herriman blvd.; noblesville, IN 46060 ; 3177766823
• MDR Report Key: 4012607
• MDR Text Key: 4955168
• Report Number: 1824226-2014-00008
• 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
• 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: XF-60
• Device Lot Number: II5BW
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2013
• Patient Sequence Number: 1