MAUDE Adverse Event Report: KING SYSTEMS PEDIATRIC ANESTHESIA BREATHING CIRCUIT; ANESTHESIA CIRCUIT

Catalog Number 2506V96

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/05/2012

Event Type  malfunction  

Event Description

High carbon dioxide levels.

• Brand Name: PEDIATRIC ANESTHESIA BREATHING 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: 4012581
• MDR Text Key: 4781331
• Report Number: 1824226-2014-00015
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/24/2014

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: 2506V96
• Device Lot Number: IXNY7
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/12/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2011
• 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