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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dc-defibrillator, low-energy, (including paddles)
Regulation Description DC-defibrillator (including paddles).
Product CodeLDD
Regulation Number 870.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
PHILIPS NORTH AMERICA, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 22 22
2022 80 83
2023 264 266
2024 160 160
2025 74 74
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 211 211
Failure to Deliver Shock/Stimulation 75 75
Pacing Problem 59 59
Unable to Obtain Readings 58 60
Failure of Device to Self-Test 41 42
Appropriate Term/Code Not Available 27 27
Insufficient Information 22 22
Break 19 19
Loose or Intermittent Connection 18 18
Failure to Charge 16 16
Device Sensing Problem 14 15
Electrical /Electronic Property Problem 10 10
Output Problem 10 10
Crack 9 9
Battery Problem 8 8
Incomplete or Inadequate Connection 8 8
Failure to Power Up 8 8
Mechanical Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Defibrillation/Stimulation Problem 7 7
Circuit Failure 6 6
Detachment of Device or Device Component 6 6
Display or Visual Feedback Problem 6 7
No Device Output 6 6
Device Handling Problem 6 6
Fitting Problem 5 5
Failure to Discharge 5 5
Erratic or Intermittent Display 5 5
Failure to Deliver Energy 5 5
Fracture 5 5
Communication or Transmission Problem 4 4
Key or Button Unresponsive/not Working 4 4
Incorrect Measurement 4 4
Protective Measures Problem 4 4
Failure to Analyze Signal 4 4
No Display/Image 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Use of Device Problem 4 4
Operating System Becomes Nonfunctional 3 3
Material Fragmentation 3 3
Grounding Malfunction 3 3
Computer Software Problem 3 3
Pacing Asynchronously 2 2
Misconnection 2 2
Pacing Inadequately 2 2
Failure to Run on Battery 2 2
Image Display Error/Artifact 2 2
High impedance 2 2
Charging Problem 2 2
No Audible Prompt/Feedback 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 508 510
Cardiac Arrest 61 64
Insufficient Information 58 58
Unspecified Heart Problem 36 36
Bradycardia 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Chest Pain 2 2
Asystole 2 2
Death 1 1
Arrhythmia 1 1
Shock from Patient Lead(s) 1 1
Twitching 1 1
Dyspnea 1 1
Heart Block 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Physio-Control, Inc. II Oct-22-2024
2 Remote Diagnostic Technologies Ltd. III Nov-26-2024
3 Remote Diagnostic Technologies Ltd. II Jun-06-2024
4 Remote Diagnostic Technologies Ltd. II Jun-12-2023
5 Remote Diagnostic Technologies Ltd. II Apr-04-2022
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