MAUDE Adverse Event Report: KING SYSTEMS KLTD 215; OROPHARYNGEAL AIRWAY

Catalog Number KLTD215

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/26/2013

Event Type  malfunction  

Event Description

Emergency medical technicians tested the airway prior to insertion and it did not remain inflated.

• Brand Name: KLTD 215
• Type of Device: OROPHARYNGEAL AIRWAY
• Manufacturer (Section D): KING SYSTEMS; noblesville IN
• Manufacturer Contact: 15011 herriman blvd.; noblesville, IN 46060 ; 3177766823
• MDR Report Key: 4012560
• MDR Text Key: 4706821
• Report Number: 1824226-2014-00016
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• PMA/PMN Number: K033186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial
• Report Date: 06/24/2014

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 Expiration Date: 08/01/2014
• Device Catalogue Number: KLTD215
• Device Lot Number: IPCW9
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/12/2013
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 06/25/2014
• 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