MAUDE Adverse Event Report: FLEXICARE MEDICAL LIMITED BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE MINI HANDLE WITH MILLER 1; LARYNGOSCOPE, RIGID

Model Number 040-06-0410U

Device Problems Failure to Power Up (1476); Intermittent Loss of Power (4016)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2020

Event Type  malfunction  

Event Description

During equipment check prior to procedure, md found two size 1 laryngoscope disposable lights were not working properly.The first laryngoscope light did not turn on during equipment check.Rn obtained a second size 1.During equipment check of the second laryngoscope, the light would turn on and off quickly; it was not suitable for use.

• Brand Name: BRITEPRO OMNI SINGLE-USE LARYNGOSCOPE MINI HANDLE WITH MILLER 1
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LIMITED; 15281 barranca parkway; unit d; irvine CA 92618
• MDR Report Key: 10778476
• MDR Text Key: 214363183
• Report Number: 10778476
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 040-06-0410U
• Device Catalogue Number: 040-06-0410U
• Device Lot Number: 180200254
• 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: 09/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1