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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE
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FLEXICARE MEDICAL LTD BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE Back to Search Results
Catalog Number FLC-040-333
Device Problem Activation Failure (3270)
Patient Problem Cardiac Arrest (1762)
Event Date 02/14/2023
Event Type  Death  
Event Description
Event occured as described by complainant below - "the light didnt work during a cardian arrest, these are on all our resuscitation carts.We checked in ceru and found that some failed as well.".
 
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Brand Name
BRITEPRO SOLO SINGLE USE FIBRE OPTIC LARYNGOSCOPE
Type of Device
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 Key16973969
MDR Text Key315665907
Report Number3006061749-2023-00013
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
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 02/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFLC-040-333
Device Lot Number200700764
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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