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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOMIMED BOMIMED; LARYNGOSCOPE BLADE
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BOMIMED BOMIMED; LARYNGOSCOPE BLADE Back to Search Results
Model Number DISPOSABLE MEDIUM
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2019
Event Type  malfunction  
Event Description
During an intubation attempt,the laryngoscope handle illumination failed after inserting the blade into the mouth and attempting to lift the tongue and mandible.The lamp was illuminated when the blade was attached to the handle and locked fully open, but turned off with the downward pressure on the blade during the lift.Releasing pressure resulted in illumination coming back on.The blade was removed and reattached to the handle with the same result.
 
Event Description
During an intubation attempt,the laryngoscope handle illumination failed after inserting the blade into the mouth and attempting to lift the tongue and mandible.The lamp was illuminated when the blade was attached to the handle and locked fully open, but turned off with the downward pressure on the blade during the lift.Releasing pressure resulted in illumination coming back on.The blade was removed and reattached to the handle with the same result.
 
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Brand Name
BOMIMED
Type of Device
LARYNGOSCOPE BLADE
Manufacturer (Section D)
BOMIMED
1-100 irene street
winnipeg, R3T 4 E1
CA  R3T 4E1
MDR Report Key9241914
MDR Text Key195577911
Report Number3003213883-2019-00002
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/22/2019
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
Device Model NumberDISPOSABLE MEDIUM
Device Catalogue NumberOL-334L6
Device Lot Number5218
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2019
Initial Date Manufacturer Received 09/25/2019
Initial Date FDA Received10/25/2019
Supplement Dates Manufacturer Received09/25/2019
Supplement Dates FDA Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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