MAUDE Adverse Event Report: KING SYSTEMS KING AIRWAY LTD

Model Number KLTD214

Device Problem Air Leak (1008)

Patient Problem Death (1802)

Event Date 09/21/2016

Event Type  Death  

Event Description

During airway management of a pt in respiratory failure, king airway was placed.Shortly thereafter, after placement of the airway device and inflation of the cuff, air began to leak from cuff.Two attempts made to re-inflate the cuff to mfr's recommendations, but the cuff began to leak after 4-5 ventilations.Device was pulled and manual management of ventilations performed with a bag-valve mask.Eventually, a second king airway placed successfully.Unfortunately, all packaging with corresponding lot number etc., was discarded at the emergency scene.

• Brand Name: KING AIRWAY LTD
• Type of Device: AIRWAY
• Manufacturer (Section D): KING SYSTEMS; nobelsville IN 46060
• MDR Report Key: 6056860
• MDR Text Key: 58480001
• Report Number: MW5065599
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2016

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 Model Number: KLTD214
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 95