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

Catalog Number 040-07-0080U

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

Event as described by complainant: monitor froze and turned off.A new amplifier cable and blade were opened and used.The monitor continued to freeze and power down.Another provu 8in was brought in to finish the intubation.

• Brand Name: PROVU VL DISPLAY
• 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: giulia sanna ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 18902683
• MDR Text Key: 337755511
• Report Number: 3006061749-2024-00008
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-07-0080U
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1