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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

MDR Year MDR Reports MDR Events
2018 14 14
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Cooling 5 5
Fluid/Blood Leak 4 4
Device Displays Incorrect Message 3 3
No Flow 2 2
Unexpected Shutdown 2 2
Temperature Problem 1 1
Application Program Problem 1 1
Fracture 1 1
Mechanical Problem 1 1
Filling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 5 5
No Patient Involvement 2 2

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