MAUDE Adverse Event Report: SUNMED GREENLINE/ D LED DISPOSABLE LARYNGOSCOPE HANDLE

Catalog Number 5-0236-69

Device Problems Device Operates Differently Than Expected (2913); Light Interference (2972)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2018

Event Type  Injury  

Event Description

The laryngoscope handle did not work/light when the blade was attached.Another blade was used but handle still did not work/light.When the connection was depressed by hand the handle would not light.

• Brand Name: GREENLINE/ D LED DISPOSABLE LARYNGOSCOPE HANDLE
• Type of Device: DISPOSABLE LARYNGOSCOPE HANDLE
• Manufacturer (Section D): SUNMED; grand rapids MI 49544
• MDR Report Key: 7384669
• MDR Text Key: 104112220
• Report Number: MW5076228
• Device Sequence Number: 2
• Product Code: CCW
• Combination Product (y/n): N
• 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: 03/28/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 5-0236-69
• Device Lot Number: 123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 47