MAUDE Adverse Event Report: BATES INDUSTRIES LLC AMBU KING LTS-D; OROPHARYNGEAL AIRWAY

Model Number KLTSD425

Device Problem Air Leak (1008)

Patient Problem Cardiac Arrest (1762)

Event Date 06/06/2017

Event Type  malfunction  

Event Description

Per complainant, "the proximal cuff of the king airway leaked air during use.The patient had no heart rhythm during transport to the hospital and was pronounced dead 15 minutes at the hospital." it is unclear whether the device had any impact on the patient's outcome.

• Brand Name: AMBU KING LTS-D
• Type of Device: OROPHARYNGEAL AIRWAY
• Manufacturer (Section D): BATES INDUSTRIES LLC; 22 hudson falls road; south glens falls NY 12803
• Manufacturer (Section G): BATES INDUSTRIES LLC; 22 hudson falls road; south glens falls NY 12803
• Manufacturer Contact: sam brayton ; 22 hudson falls road; south glens falls, NY 12803 ; 5187478730
• MDR Report Key: 6694338
• MDR Text Key: 79758240
• Report Number: 1824226-2017-00004
• Device Sequence Number: 1
• Product Code: CAE
• 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: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Emergency Medical Technician
• Device Model Number: KLTSD425
• Device Catalogue Number: KLTSD425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 06/09/2017
• Supplement Dates FDA Received: 08/03/2017
• 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
• Patient Outcome(s): Death