MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU UNIVERSAL REUSABLE 8" DISPLAY, CHARGING CABLE AND 2 M AMPLIFIER EXTENSION; VIDEO LARYNGOSCOPE

Catalog Number 040-07-0080U

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2023

Event Type  malfunction  

Event Description

Event occured as described below by complainant - "the provu blave failed during our intubation attempt on known difficult airway.Failure led to delay in securing airway and unnecessary airway manipulations.The device was plugged in to wall.The machine and cable have also been labeled for "repair".Biomed checked the 8" monitor and cable for function with the same blade afterward and found them to be working.".

Manufacturer Narrative

Unable to send report via webtrader on (b)(6) 2023.Email sent to cdrh emdr on (b)(6) 2023 at 15:03 bst with details of issue and estimated time to correct the issue.

• Brand Name: PROVU UNIVERSAL REUSABLE 8" DISPLAY, CHARGING CABLE AND 2 M AMPLIFIER EXTENSION
• 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: 16599170
• MDR Text Key: 312308394
• Report Number: 3006061749-2023-00006
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-07-0080U
• Device Lot Number: 220501663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention