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

Catalog Number D360-61

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

Breathing bag is separating from bushing.No adverse events.

• Brand Name: UNIVERSAL F2 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: 4012372
• MDR Text Key: 19588908
• Report Number: 1824226-2014-00006
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/19/2014

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: D360-61
• Device Lot Number: I15YJ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/19/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2013
• Was Device Evaluated by Manufacturer?: Yes
• 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