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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aid, cardiopulmonary resuscitation
Regulation Description Cardiopulmonary resuscitation (CPR) aid.
Definition CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software
Product CodeLIX
Regulation Number 870.5210
Device Class 2


Premarket Reviews
ManufacturerDecision
CREDO
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2023 10 10
2024 5 5
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 2 2
Difficult to Remove 2 2
Detachment of Device or Device Component 2 2
Sparking 1 1
Break 1 1
Separation Failure 1 1
Smoking 1 1
Adhesive Too Strong 1 1
Material Twisted/Bent 1 1
Gel Leak 1 1
Connection Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Superficial (First Degree) Burn 2 2
Arrhythmia 2 2
Insufficient Information 2 2
Burn(s) 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Heart Problem 1 1

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