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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device patient monitor with independent remote display and operation
Definition Monitors intended for the remote display and operation of patient physiological monitors, including alarm functionality, signal analysis, and data recording during declared public health emergency.
Product CodeQLJ
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 2 2
2023 2 2
2024 24 24
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 19 19
Device Displays Incorrect Message 18 18
Low Readings 6 6
High Readings 3 3
Application Program Problem 1 1
Calibration Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Loss of consciousness 21 21
Hypoglycemia 16 16
Convulsion/Seizure 7 7
Dizziness 6 6
Hyperglycemia 4 4
Nausea 3 3
Insufficient Information 3 3
Fatigue 2 2
Diaphoresis 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Fever 1 1
Pain 1 1
Headache 1 1
Hot Flashes/Flushes 1 1

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