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 Output Problem (3005)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

Event as described by complainant: the provu monitor freezes and blinks during intubations.When a new amplifier cable was used, the screen was still glitching.The screen then displayed an internal error.Another provu stand was used.

• 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: giulia sanna ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 19141775
• MDR Text Key: 340585426
• Report Number: 3006061749-2024-00018
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-07-0080U
• Device Lot Number: XUPD60968
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2023
• 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