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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLEXICARE MEDICAL LIMITED BRITEPRO OMNI- MAC 4; LARYNGOSCOPE, RIGID
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FLEXICARE MEDICAL LIMITED BRITEPRO OMNI- MAC 4; LARYNGOSCOPE, RIGID Back to Search Results
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem Low Oxygen Saturation (2477)
Event Date 09/24/2020
Event Type  malfunction  
Event Description
Patient with acute aspiration of bloody secretions.Prior to administering sedation and neuromuscular blockade i checked the mac 4 laryngoscope to confirm it was functional.When lifting in valecula with laryngoscope, light bulb would become too dim to see every time there was pressure on the blade.I had a second blade in the room, but it was not my preferred shape.Instead had someone hand me another mac 4 laryngoscope from the airway cart which was positioned at the door to the room.This one worked appropriately.As a result, patient desaturate to sat of 50s, instead of low 80s where we were when i was ready to intubate with the first laryngoscope.I suspect he also had greater volume aspirated into lungs.This is the second time i have experienced this malfunction with this device.
 
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Brand Name
BRITEPRO OMNI- MAC 4
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
FLEXICARE MEDICAL LIMITED
15281 barranca parkway
unit d
irvine CA 92618
MDR Report Key10635216
MDR Text Key210019409
Report Number10635216
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/25/2020
Event Location Hospital
Date Report to Manufacturer10/06/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age27375 DA
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