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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
LAERDAL MEDICAL AS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 2 2
2018 2 2
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Crack 1 1
Disconnection 1 1
Smoking 1 1
Arcing 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Partial thickness (Second Degree) Burn 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips Electronics North America Corporation II Feb-22-2018
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