MAUDE Adverse Event Report: FLEXICARE INC. BRITEPRO SOLO LARYNGOSCOPE

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 01/03/2018

Event Type  malfunction  

Event Description

This is being reported as a patient safety concern.This is the second time within 2 months for a disposable single use laryngoscope not to work properly and requiring for staff to open a second scope during a code and intubation.Staff is reporting that the light does not work.

• Brand Name: BRITEPRO SOLO LARYNGOSCOPE
• Type of Device: BRITEPRO SOLO LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE INC. ; 15281 barranca pkwy.; unit d; irvine CA 92618
• MDR Report Key: 7230513
• MDR Text Key: 98760563
• Report Number: MW5074972
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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