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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 Problems No Display/Image (1183); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2023
Event Type  malfunction  
Event Description
Description of event as described by complainant below - "monitor - (b)(6) the monitor will not accept an amplifier cable, new or old monitor - (b)(6): the monitor is fully charged at 100% and was used in an emergency airway case.The monitor screen was blanking out during intubation and it shut off.The monitor was repowerd and the screen shut off again, ambu was used in replace.".
 
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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 Key18244865
MDR Text Key329434857
Report Number3006061749-2023-00020
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
Type of Report Initial
Report Date 12/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number040-07-0080U
Device Lot NumberXURD628718, XUTD63217
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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