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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, heart rate, fetal, ultrasonic
Product CodeHEL
Regulation Number 884.2660
Device Class 2

MDR Year MDR Reports MDR Events
2019 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 5 5
No Apparent Adverse Event 3 3
Operating System Becomes Nonfunctional 2 2
Break 2 2
Crack 2 2
Calibration Problem 2 2
Electrical Shorting 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Patient Involvement 2 2

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