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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD PROVU UNIVERSAL 8" DISPLAY, CHARGING CABLE AND 2M AMPLIFING EXTENSION CABLE; LARYNGOSCOPE
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FLEXICARE MEDICAL LTD PROVU UNIVERSAL 8" DISPLAY, CHARGING CABLE AND 2M AMPLIFING EXTENSION CABLE; LARYNGOSCOPE Back to Search Results
Catalog Number 040-07-0080U
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2022
Event Type  malfunction  
Event Description
Description of the event as reported in (b)(6) 'physician was in the middle of intubation and the provu monitor screen started glitching.The physician described the screen as though it looked like an x-ray screen.The light on the blade went out and the physician had to act quick and use an lma as the patient was already under.'.
 
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Brand Name
PROVU UNIVERSAL 8" DISPLAY, CHARGING CABLE AND 2M AMPLIFING EXTENSION CABLE
Type of Device
LARYNGOSCOPE
Manufacturer (Section D)
FLEXICARE MEDICAL LTD
cynon valley business park
mountain ash, rct CF45 4ER
UK  CF45 4ER
Manufacturer (Section G)
FLEXICARE MEDICAL DONGGUAN
no. b-15 xicheng ind zone 1
hengli town
dongguan city,
CH  
Manufacturer Contact
julie davies
cynon valley business park
mountain ash, rct CF45 -4ER
UK   CF45 4ER
MDR Report Key15866717
MDR Text Key307895310
Report Number3006061749-2022-00019
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 Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number040-07-0080U
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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