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

Model Number DF370-6121Z

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

During a medical procedure at (b)(6), a pt became desaturated.The anesthesiologist not knowing the cause of the desaturation, attempted to decouple the coaxial breathing circuit from the anesthesia machine and in doing so, pulled the external corrugated hose away from filter exposing the inner hose and inadvertently disassembling the breathing circuit.The inner hose appeared irregular.The cause of the desaturation was not specified.

Manufacturer Narrative

Date of report is (b)(6) 2015.Original report had a typo indicating date of report as (b)(6)2015.

Event Description

During a medical procedure at montefiore hospital in the (b)(6), a patient became desaturated.The anesthesiologist not knowing the cause of the desaturation, attempted to decouple the coaxial breathing circuit from the anesthesia machine and in doing so, pulled the external corrugated hose away from filter exposing the inner hose and inadvertently disassociating the breathing circuit.The inner hose appeared irregular.The cause of the desaturation was not specified.

Manufacturer Narrative

Updated sections due to evaluation of the device.

• Brand Name: UNIVERSAL FLEX2 CIRCUIT
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS; noblesville IN
• MDR Report Key: 4729602
• MDR Text Key: 19509123
• Report Number: 1824226-2015-00001
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DF370-6121Z
• Device Catalogue Number: DF370-6121Z
• Device Lot Number: I1SIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2015
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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