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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEINE OPTOTECHNIK GMBH & CO. KG HEINE SIZE 3 MAC PLASTIC LARYNGOSCOPE BLADE; DISPOSABLE LARYNGOSCOPE BLADE
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HEINE OPTOTECHNIK GMBH & CO. KG HEINE SIZE 3 MAC PLASTIC LARYNGOSCOPE BLADE; DISPOSABLE LARYNGOSCOPE BLADE Back to Search Results
Catalog Number F-000.22.763
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 06/05/2020
Event Type  malfunction  
Event Description
When using size 3 plastic laryngoscope blade with handle, the light was very dim and flickered.
 
Event Description
When using size 3 plastic laryngoscope blade with handle, the light was very dim and flickered.This was a one-time occurrence with these devices.Staff believes the handles did not seat properly on the blade ensuring a tight connection.There was no delay of care and there were other options available for the procedure.The prior risk manager and emergency department manager did not retain these items.The have been no new instances reported of failure.
 
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Brand Name
HEINE SIZE 3 MAC PLASTIC LARYNGOSCOPE BLADE
Type of Device
DISPOSABLE LARYNGOSCOPE BLADE
Manufacturer (Section D)
HEINE OPTOTECHNIK GMBH & CO. KG
10 innovation way
dover NH 03820
MDR Report Key10939868
MDR Text Key219327358
Report Number10939868
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 11/18/2020
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
Device Catalogue NumberF-000.22.763
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2020
Date Report to Manufacturer12/03/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/03/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age22995 DA
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