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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, apnea, home use
Definition Same as the identification for product code FLS, just add home use
Product CodeNPF
Regulation Number 868.2377
Device Class 2

MDR Year MDR Reports MDR Events
2018 24 24
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 20 20
Loose or Intermittent Connection 2 2
Device Emits Odor 1 1
Overheating of Device 1 1
Smoking 1 1
Solder Joint Fracture 1 1
Communication or Transmission Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 22 22
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1

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