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

Catalog Number 040-07-0080U

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Event Description

Description of event as described by complainant - "(b)(6) intubated patient.Et tube dislodged and he had to reintubate.He connected blue cable to blade and a blue screen came up.He then tried another blade and it didnt work.He then tried another and it did work.This happened twice.Dr.Kolm also had a occurence where he connected blue cable and blue picture showed, and it didnt work.Dr.Kolm then tried another blade and it did work.".

• 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: 18244864
• MDR Text Key: 329439789
• Report Number: 3006061749-2023-00021
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 040-07-0080U
• Device Lot Number: XUWS49983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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