MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU; VIDEO LARYNGOSCOPE

Catalog Number 040-08-2140U

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2023

Event Type  Injury  

Event Description

Description of event is below as reported by complainant - "pt.Requiring intubation during a code blue.Provu device (stand) utilizes, 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 thing happened.A new blade was obtained, and the device worked.This caused a delay in intubation.".

• Brand Name: PROVU
• Type of Device: VIDEO LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cwm cynon business park; mountain ash, rct CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL LTD (CHINA); no.b-15; xicheng industrial zone; dongguan, guangdong 52346 5; CH 523465
• Manufacturer Contact: alex mcdonough ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 16859021
• MDR Text Key: 314440777
• Report Number: 3006061749-2023-00007
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 040-08-2140U
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other