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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT MEDICAL MALLINCKRODT; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
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MALLINCKRODT MEDICAL MALLINCKRODT; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE Back to Search Results
Model Number 125-20
Device Problem Material Discolored (1170)
Patient Problem No Patient Involvement (2645)
Event Date 07/19/2018
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 has been stored and the green bag was discolored.There was no patient involvement.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation.Visual examination of the returned unit shows the green neoprene bag is discolored in two places.The reported defect could be detected on the returned sample.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
MALLINCKRODT
Type of Device
ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
Manufacturer (Section D)
MALLINCKRODT MEDICAL
cornamaddy
athlone 3810
MDR Report Key7747305
MDR Text Key116379826
Report Number8020889-2018-00076
Device Sequence Number1
Product Code BYE
Combination Product (y/n)N
PMA/PMN Number
K912240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/01/2020
Device Model Number125-20
Device Catalogue Number125-20
Device Lot Number201507151X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2019
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2015
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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