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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 040-07-0035
Device Problems Premature Discharge of Battery (1057); Failure to Run on Battery (1466)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2023
Event Type  malfunction  
Event Description
As described by complainer: "user removed provu monitor from charger and confirmed 99% battery.User attempted to intubate a patient 30 minutes after removing the provu monitor from the charger and the provu monitor powered off when connected to handle.The user powered the monitor back on and it states 0% battery before shutting off again.".
 
Manufacturer Narrative
(b)(4).
 
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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
julie davies
cwm cynon business park
mountain ash, rct CF45 -4ER
UK   CF45 4ER
MDR Report Key18921592
MDR Text Key337871663
Report Number3006061749-2023-80014
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 Administrator/Supervisor
Type of Report Initial
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number040-07-0035
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/14/2023
Initial Date FDA Received03/18/2024
Was Device Evaluated by Manufacturer? No
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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