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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU VL DISPLAY; VIDEO LARYNGOSCOPE
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FLEXICARE MEDICAL LTD PROVU VL DISPLAY; VIDEO LARYNGOSCOPE Back to Search Results
Catalog Number 040-07-0080U
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2023
Event Type  malfunction  
Event Description
Event as described by complainant: account contract flexicare stating that their 8" provu monitor turned off during intubation.The monitor had a new amplier cable attached and was also connected to a new blade.However the light continued to shut off after connection.Connectivity seems to be questionable and account is requesting a replacement monitor.
 
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Brand Name
PROVU VL DISPLAY
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 Key18282853
MDR Text Key330353313
Report Number3006061749-2023-00022
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 12/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number040-07-0080U
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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