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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY
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MALLINCKRODT MEDICAL SHILEY; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY Back to Search Results
Model Number 125137
Device Problems Defective Component (2292); Human-Device Interface Problem (2949)
Patient Problem Unintended Extubation (4564)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the device fiber optic scope was very difficult to remove from the endobronchial tube.Obstruction was re ported and unable to fully place the scope down the tube without getting stock and to pulled it out forcefully.It was reported that the customer noted that it was the diameter of the tube that was getting stuck, but the diameter of the scope should have fit through the tube after looking at scope cross reference chart.Another scope had tried and reintubation was done.
 
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Brand Name
SHILEY
Type of Device
ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY
Manufacturer (Section D)
MALLINCKRODT MEDICAL
cornamaddy
athlone 3810
EI  3810
MDR Report Key12051114
MDR Text Key262951291
Report Number8020889-2021-00065
Device Sequence Number1
Product Code BYE
UDI-Device Identifier10884521620025
UDI-Public10884521620025
Combination Product (y/n)N
PMA/PMN Number
K912240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number125137
Device Catalogue Number125137
Was Device Available for Evaluation? No
Date Manufacturer Received06/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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