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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
2017 12 12
2018 14 14
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 7 7
Insufficient Cooling 6 6
Fluid Leak 5 5
Device Displays Incorrect Message 5 5
Device Operates Differently Than Expected 3 3
No Flow 2 2
Power Problem 2 2
Unexpected Shutdown 2 2
Device Stops Intermittently 2 2
Inability to Auto-Fill 1 1
Application Program Problem 1 1
Fracture 1 1
Mechanical Problem 1 1
No Display/Image 1 1
Filling Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15 15
No Consequences Or Impact To Patient 12 12
No Patient Involvement 2 2
Hypoxia 1 1

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