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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU; VIDEO LARYNGOSCOPE
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FLEXICARE MEDICAL LTD PROVU; VIDEO LARYNGOSCOPE Back to Search Results
Catalog Number 040-07-0080U
Device Problem Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2024
Event Type  malfunction  
Event Description
As described by complainant - "account emailed that they had an issue in (b)(6) while using the provu: the image froze while the anestheiologist was visualising the cords.The image then reverted back to the blue start screen showing everything as connected.The staff the only way they were able to get it to work was to plug the unit it, despite it saying it had 90% battery power".
 
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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
alex mcdonough
cwm cynon business park
mountain ash, rct CF45 -4ER
UK   CF45 4ER
MDR Report Key18709995
MDR Text Key335408969
Report Number3006061749-2024-00004
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 Consumer,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number040-07-0080U
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/16/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/30/2021
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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