MAUDE Adverse Event Report: FLEXICARE MEDICAL LIMITED BRITEPRO SOLO MINI SINGLE-USE FIBER OPTIC LARYNGOSCOPE HANDLE; LARYNGOSCOPE, RIGID

Model Number 040-309U

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 09/05/2023

Event Type  Other  

Event Description

Pediatric cpr arrived to er.I was preparing for intubation when it was discovered that the mac 2 blade and handle were not working properly.The light on the blade would not illuminate.An additional handle and blade could not be found in the broslow cart.Patient was intubated successfully with equipment from the airway cart provided by respiratory.

• Brand Name: BRITEPRO SOLO MINI SINGLE-USE FIBER OPTIC LARYNGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LIMITED; 15281 barranca pkwy, unit d; irvine CA 92618
• MDR Report Key: 17833511
• MDR Text Key: 324462103
• Report Number: 17833511
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/11/2023,09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 040-309U
• Device Catalogue Number: 040-309U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2023
• Date Report to Manufacturer: 09/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1