MAUDE Adverse Event Report: COOKGAS LLC AIR-Q DISPOSABLE; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number 3035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Sore Throat (2396)

Event Date 04/06/2017

Event Type  malfunction  

Event Description

Patient had an orthopedic procedure of his lower leg with monitored anesthesia care using a laryngeal mask airway (lma) and in the pacu upon waking was unable to speak and was able to whisper only with difficulty and was unable to cough.He was saturating 100% on room air, lungs clear, no stridor.Evaluated by oral maxillofacial surgery (omf) consult and there was no evidence of injury, trauma or inflammation of the vocal cords and it was unclear what caused the vocal cord abnormality.The lma placement in the or was straightforward which sits above the glottis and does not pass through the vocal cords.There were no indications from the ventilation data that the lma was not working properly.

• Brand Name: AIR-Q DISPOSABLE
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): COOKGAS LLC; 1101 lucas ave.; ste 200; st. louis MO 63101
• MDR Report Key: 6518551
• MDR Text Key: 73598236
• Report Number: 6518551
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3035
• Device Catalogue Number: 10-3035
• Other Device ID Number: SMALL ADULT, 3.5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 63