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

Catalog Number 040-07-0080U

Device Problem No Display/Image (1183)

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

Event Date 03/29/2024

Event Type  malfunction  

Event Description

The event details as reported to manufacturing " this was a critical case, patient with pancreatic cancer with strong susceptibility to bleeding.When going into intubate, the provu 8" monitor screen blacked and no longer displayed video.They retracted the blade, decommissioned the monitor, began bagging the patient and obtained a functioning provu 3.5" monitor to intubate with.They were able to successfully complete the intubation with no adverse outcome".

• 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: julie davies ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 19191667
• MDR Text Key: 341260441
• Report Number: 3006061749-2024-00019
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1