MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU UNIVERSAL 8" DISPLAY, CHARGING CABLE AND 2M AMPLIFING EXTENSION CABLE; LARYNGOSCOPE

Catalog Number 040-07-0020U

Device Problem Insufficient Information (3190)

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

Event Date 10/27/2022

Event Type  malfunction  

Event Description

Description of the event as reported 'physicians was intubating and the provu display screen started glitching.The light on the blade would not turn on and the screen resembled that of an x-ray screen (black and 3d like).The cable was bent/broke at the connection side of the monitor'.

• Brand Name: PROVU UNIVERSAL 8" DISPLAY, CHARGING CABLE AND 2M AMPLIFING EXTENSION CABLE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cynon valley business park; mountain ash, rct CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, ; CH
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 15866718
• MDR Text Key: 307703171
• Report Number: 3006061749-2022-00020
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-07-0020U
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1