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

Catalog Number 040-07-0035U

Device Problem Insufficient Information (3190)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

Addtional information provided event description details that the remidal actions taken by healthcare facility was 'after this one failed, grabbed another monitor and used that to intubate.'.

Event Description

The event description is described as 'during use, monitor was turned on, went blank and could not get back on.Button stuck in down position.'.

• Brand Name: PROVU 3.5" VIDEO LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cynon valley business park; mountain ash, rct CF454 ER; UK CF454ER
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF454-ER ; UK CF454ER
• MDR Report Key: 16034423
• MDR Text Key: 308448429
• Report Number: 3006061749-2022-00026
• 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
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 11/28/2022

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: 040-07-0035U
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1