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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
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES, LTD, A PHILIPS COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 34 34
2020 19 19
2021 22 22
2022 80 80
2023 264 264
2024 160 160
2025 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 209 209
Failure to Deliver Shock/Stimulation 89 89
Pacing Problem 56 56
Unable to Obtain Readings 54 54
Failure of Device to Self-Test 40 40
Appropriate Term/Code Not Available 27 27
Insufficient Information 22 22
Loose or Intermittent Connection 18 18
Break 17 17
Device Sensing Problem 11 11
Failure to Charge 11 11
Electrical /Electronic Property Problem 10 10
Output Problem 10 10
Failure to Deliver Energy 9 9
Therapeutic or Diagnostic Output Failure 9 9
Failure to Power Up 9 9
Mechanical Problem 8 8
Incomplete or Inadequate Connection 6 6
Failure to Discharge 6 6
No Device Output 6 6
Circuit Failure 6 6
Battery Problem 6 6
Detachment of Device or Device Component 6 6
Defibrillation/Stimulation Problem 6 6
Device Handling Problem 6 6
Display or Visual Feedback Problem 5 5
Crack 5 5
Fitting Problem 5 5
Fracture 5 5
Erratic or Intermittent Display 5 5
Use of Device Problem 5 5
Communication or Transmission Problem 4 4
Failure to Analyze Signal 4 4
Grounding Malfunction 4 4
Intermittent Continuity 4 4
Protective Measures Problem 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Incorrect Measurement 4 4
No Display/Image 3 3
Defective Component 3 3
Computer Software Problem 3 3
Material Fragmentation 3 3
Mechanical Jam 2 2
Connection Problem 2 2
Power Problem 2 2
Low impedance 2 2
Activation Failure 2 2
Pacing Asynchronously 2 2
Misconnection 2 2
Use of Incorrect Control/Treatment Settings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 475 475
Insufficient Information 57 57
Cardiac Arrest 55 55
Unspecified Heart Problem 36 36
No Patient Involvement 31 31
Bradycardia 7 7
No Information 6 6
No Consequences Or Impact To Patient 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Death 5 5
No Known Impact Or Consequence To Patient 3 3
Shock from Patient Lead(s) 2 2
Ventricular Fibrillation 2 2
Chest Pain 2 2
Asystole 2 2
Arrhythmia 1 1
Skin Irritation 1 1
Burn, Thermal 1 1
Swelling 1 1
Twitching 1 1
Dyspnea 1 1
Heart Block 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
6 Remote Diagnostic Technologies Ltd. II Dec-11-2020
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