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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 040-07-0800U
Device Problem No Display/Image (1183)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2024
Event Type  malfunction  
Event Description
As described by complainant - "account contacted flexicare to complaint that 8" provu monitor image continues to freeze during intubations.They stated that this has occured on multiple occasions, even after switching out the amplifier cable.".
 
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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 Key18805681
MDR Text Key337629088
Report Number3006061749-2024-00005
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 02/29/2024
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 Number040-07-0800U
Device Lot NumberXUWS50028
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2024
Initial Date FDA Received02/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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