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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device auxiliary power supply (ac or dc) for low-energy dc-defibrillator
Regulation Description DC-defibrillator (including paddles).
Product CodeMPD
Regulation Number 870.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER PHYSIO-CONTROL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 11 11
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Power Problem 7 7
Defective Device 2 2
Output Problem 1 1
Device Stenosis 1 1
Defective Component 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Thrombosis/Thrombus 1 1
Chest Pain 1 1
Tachycardia 1 1
Cough 1 1

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