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

Model Number 040-309U

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2022

Event Type  malfunction  

Event Description

Laryngoscope handle pulled for stat lisa (less invasive surfactant administration) procedure on infant.Light in handle did not work.

• 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: 15751454
• MDR Text Key: 303235868
• Report Number: 15751454
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 040-309U
• Device Lot Number: 200604126
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Sex: Female
• Patient Weight: 3 KG