MAUDE Adverse Event Report: FLEXICARE, INC. BRITEPRO SOLO OMNI; LARYNGOSCOPE, RIGID

Catalog Number 040-04-0440U

Device Problem Energy Output Problem (1431)

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

Event Date 07/25/2019

Event Type  malfunction  

Event Description

Miller 4 britepro omni laryngoscope would not light up the ref number is 0400404011 lot 190102039 exp 12/01/2023 was not used on a patient but the laryngoscope will not light up.

• Brand Name: BRITEPRO SOLO OMNI
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE, INC.; 15281 barranca parkway; unit d; irvine CA 92618
• MDR Report Key: 8926173
• MDR Text Key: 155385058
• Report Number: 8926173
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-04-0440U
• Device Lot Number: 190102039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1