MAUDE Adverse Event Report: KING AIRWAY

Lot Number 107DY

Device Problem Defective Device (2588)

Patient Problem Hypoxia (1918)

Event Date 07/02/2016

Event Type  Injury  

Event Description

After inserting king airway, providers identified issue with 15 mm adapter.The adapter was oblong shaped instead of circular preventing connecting to the bag valve device.Due to the defect in the tube adapter, the device was removed and a new one was placed causing delay in securing the airway.A period of hypoxia occurred between insertion, removal and ventilation support.Distributor is boundtree medical.Have contacted the regional top ryan rigsby.Dates of use: (b)(6)2016.

• Brand Name: KING AIRWAY
• Type of Device: KING
• MDR Report Key: 5795441
• MDR Text Key: 49640150
• Report Number: MW5063416
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/11/2016

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: 07/01/2016
• Device Lot Number: 107DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR
• Patient Weight: 130