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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cap, cooling (infants)
Definition Indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE)*. Provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.
Product CodeMXM
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 2 0 1 2 0 0 0 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2016 11 11
2017 12 12
2018 14 14
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Cooling 7 7
Use of Device Problem 7 7
Device Displays Incorrect Message 5 5
Fluid/Blood Leak 5 5
No Display/Image 4 4
Device Operates Differently Than Expected 4 4
Device Stops Intermittently 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
No Flow 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Power Problem 2 2
Unexpected Shutdown 2 2
Temperature Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Application Program Problem 1 1
Computer Operating System Problem 1 1
Display or Visual Feedback Problem 1 1
Filling Problem 1 1
Inability to Auto-Fill 1 1
Fracture 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 18 18
No Known Impact Or Consequence To Patient 17 17
No Patient Involvement 2 2
Tissue Breakdown 2 2
Death 2 2
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Natus Medical Incorporated I Nov-30-2012
2 Natus Medical Incorporated II Jun-20-2012
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