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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device monitor, apnea, facility use
Regulation Description Apnea monitor.
Product CodeFLS
Regulation Number 868.2377
Device Class 2

MDR Year MDR Reports MDR Events
2016 3 3
2018 4 4
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 4 4
Defective Alarm 3 3
Adverse Event Without Identified Device or Use Problem 2 2
No Audible Alarm 1 1
Solder Joint Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6 6
No Patient Involvement 1 1
Apnea 1 1

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