MAUDE Adverse Event Report: VERATHON GLIDESCOPE

Model Number PORTABLE GVL

Device Problem Difficult To Position (1467)

Patient Problem Pneumothorax (2012)

Event Date 04/27/2016

Event Type  Injury  

Event Description

Infant was intubated with a size 3 ett with use of a glidescope.After 3 attempts anesthesiologist was unsuccessful.A couple more attempts were made by the ent md.Chest x-rays were done and infant was found with right pneumothorax, pneumopericardium and a pneumomediastinum.Infant also suffered a tracheal perforation.Chest tube was inserted and patient was transferred to another hospital.

• Brand Name: GLIDESCOPE
• Type of Device: GLIDESCOPE
• Manufacturer (Section D): VERATHON ; 200001 north creek pkwy ; bothell WA 98011
• MDR Report Key: 5681819
• MDR Text Key: 46071954
• Report Number: 5681819
• Device Sequence Number: 1
• Product Code: CCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2016,05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PORTABLE GVL
• Device Catalogue Number: 0231-0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2016
• Distributor Facility Aware Date: 04/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 3 YR
• Patient Weight: 3