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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
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
2019 1 1
2021 1 1
2023 10 10
2024 3 3

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 2 2
Arrhythmia 2 2
Superficial (First Degree) Burn 2 2
Partial thickness (Second Degree) Burn 1 1
Unspecified Heart Problem 1 1
Death 1 1

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