MAUDE Adverse Event Report: VERATHON INC. SPECTRUM GLIDESCOPE; LARYNGOSCOPE, RIGID

Model Number 0574-0194

Device Problems No Display/Image (1183); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/14/2020

Event Type  malfunction  

Event Description

Discovered glide scope screen not working.Only turned yellow.Brand new straight out of the package.Fda safety report id# (b)(4).

• Brand Name: SPECTRUM GLIDESCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON INC.
• MDR Report Key: 10295271
• MDR Text Key: 199722839
• Report Number: MW5095595
• Device Sequence Number: 1
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2023
• Device Model Number: 0574-0194
• Device Lot Number: GT64338
• 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