MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD BRITEPRO SOLO MINI; LARYNGOSCOPE

Catalog Number 040-310U, 040-309U

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Arrest (1762)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

The descripiton of the problem as reported in medwatch ' device was hard to use'.

Manufacturer Narrative

Flexicare has reached out to the hosptial, the hospital could not confirm the exact product code and the exact blade had been discarded.The facilty confirmed the flexicare laryngoscope was not the cause of the adverse event or death, and that it was an extremly high risk intubation and there was a high chance of cardiac arrest from intubating the patient.

• Brand Name: BRITEPRO SOLO MINI
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cynon valley business park; mountain ash, CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 15924496
• MDR Text Key: 308070699
• Report Number: 3006061749-2022-00023
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-310U, 040-309U
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2633020000-2022-8016
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 5 KG