MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD. PROVU VIDEO LARYNGOSCOPE WITH HYPER ANGULATED BLADE; LARYNGOSCOPE, RIGID

Model Number SIZE 4

Device Problem Inadequate User Interface (2958)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2023

Event Type  Injury  

Event Description

Pt.Requiring intubation during a code blue.Provu device (stand) utilized, the screen cut off and showed that a blade needed to be plugged in ¿ the blade was plugged in.The portable provu device was obtained and the same blade was used and the same thing happened.A new blade was obtained, and the device worked.This caused a delay with intubation.

• Brand Name: PROVU VIDEO LARYNGOSCOPE WITH HYPER ANGULATED BLADE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): FLEXICARE MEDICAL LTD.
• MDR Report Key: 16645369
• MDR Text Key: 312541950
• Report Number: MW5116122
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIZE 4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American