MAUDE Adverse Event Report: KING SYSTEMS CORP. UNIVERSAL F FLEX CIRCUIT; BREATHING CIRCUIT

Model Number FF370-61Z

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/07/2015

Event Type  malfunction  

Event Description

When starting anesthesia induction, it was observed that no oxygen was being delivered to the pt.It appeared that the breathing circuit was collapsed.There was no injury to the pt.

Manufacturer Narrative

It appears that the breathing circuit was not tested prior to use per the instructions for use.

• Brand Name: UNIVERSAL F FLEX CIRCUIT
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): KING SYSTEMS CORP.; noblesville IN
• Manufacturer Contact: 15011 herriman blvd.; noblesville, IN 46060 ; 3177763175
• MDR Report Key: 4877730
• MDR Text Key: 17215150
• Report Number: 1824226-2015-00003
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF370-61Z
• Device Catalogue Number: FF370-61Z
• Device Lot Number: 1670807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/29/2015
• 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