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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH

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AIRCRAFT MEDICAL LIMITED MCGRATH Back to Search Results
Model Number 300-000-000
Device Problem Image Display Error/Artifact (1304)
Patient Problem Extubate (2402)
Event Date 12/11/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the unit display disappeared when the angle of the monitor liquid crystal part was changed.The customer stated recannulation of a replacement tube required.The customer indicated that there was no patient harm associated with this event.
 
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Brand Name
MCGRATH
Manufacturer (Section D)
AIRCRAFT MEDICAL LIMITED
7 cross way
dalgety bay,fi KY11 9JE
GB  KY11 9JE
Manufacturer (Section G)
AIRCRAFT MEDICAL LIMITED
7 cross way
dalgety bay,fi KY11 9JE
GB   KY11 9JE
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key8228533
MDR Text Key132484035
Report Number3010244187-2019-00002
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 01/08/2019
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 Model Number300-000-000
Device Catalogue Number300-000-000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2018
Initial Date FDA Received01/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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