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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2022
Event Type  malfunction  
Event Description
The details of the event as described "monitor shut off during mid coded obsese patient for icu medical director".
 
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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, CF45 4ER
UK  CF45 4ER
Manufacturer (Section G)
FLEXICARE MEDICAL DONGGUAN
no. b-15 xicheng ind zone 1
hengli town
dongguan city, guangdong 52346 0
CH   523460
Manufacturer Contact
julie davies
cynon valley business park
mountain ash, rct CF45 -4ER
UK   CF45 4ER
MDR Report Key16252258
MDR Text Key309016349
Report Number3006061749-2023-00001
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/27/2023
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 Number040-07-0080U
Device Lot NumberNOT GIVEN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/30/2022
Initial Date FDA Received01/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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