ETT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for ETT manufactured by Mallinckrodt.

Event Text Entries

[184278536] Per staff report, they were having trouble keeping patient oxygenated and identified a possible air leak. Tube was later changed out.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9859953
MDR Report Key9859953
Date Received2020-03-20
Date of Report2020-01-30
Date of Event2020-01-27
Report Date2020-01-30
Date Reported to FDA2020-01-30
Date Reported to Mfgr2020-03-20
Date Added to Maude2020-03-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameETT
Product CodeBTR
Date Received2020-03-20
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMALLINCKRODT
Manufacturer Address6603 FEMRITE DR MADISON WI 53718 US 53718


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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