MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU REUSABLE 3.5" VIDEO LARYNGOSCOPE

Catalog Number 040-07-0035U

Device Problem Output Problem (3005)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

Event as described by complainant: video went out on 2 units while being used on a patient.I spoke to customer and both patients were eventually intubated."1) i had it on a code and the battery was at 86% but the light on the blade would be on for a second and then shut off.It was on a mac 4 and then i tested it on a different mac 3 and it did the same thing.I have this camera in my possetion, i have chardeg it fully (i received it dead) and have tested it with blades i have here for training, and it is working.I am unable to replicate the problem.2) tonight while on a call in the middle of intubation, the screen went blye with error messages.We took the screen off, put it back and it gave the same error.We took ti off one more time and put it back and it worked".

• Brand Name: PROVU REUSABLE 3.5" VIDEO LARYNGOSCOPE
• 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: 18874500
• MDR Text Key: 337318086
• Report Number: 3006061749-2024-00007
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/11/2024

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: 040-07-0035U
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2023
• 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