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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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 203 203
Failure to Deliver Shock/Stimulation 82 82
Pacing Problem 54 54
Unable to Obtain Readings 47 47
Failure of Device to Self-Test 39 39
Appropriate Term/Code Not Available 27 27
Insufficient Information 22 22
Loose or Intermittent Connection 17 17
Break 14 14
Failure to Charge 11 11
Device Sensing Problem 10 10
Output Problem 10 10
Failure to Deliver Energy 9 9
Electrical /Electronic Property Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Failure to Power Up 8 8
Mechanical Problem 7 7
Incomplete or Inadequate Connection 6 6
Circuit Failure 6 6
Device Handling Problem 6 6
No Device Output 6 6
Battery Problem 6 6
Detachment of Device or Device Component 6 6
Fitting Problem 5 5
Display or Visual Feedback Problem 5 5
Failure to Discharge 5 5
Communication or Transmission Problem 4 4
Failure to Analyze Signal 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Incorrect Measurement 4 4
Grounding Malfunction 4 4
Use of Device Problem 4 4
Defibrillation/Stimulation Problem 4 4
Intermittent Continuity 4 4
Erratic or Intermittent Display 4 4
Material Fragmentation 3 3
No Display/Image 3 3
Defective Component 3 3
Computer Software Problem 3 3
Fracture 3 3
Protective Measures Problem 3 3
Crack 2 2
Image Display Error/Artifact 2 2
High impedance 2 2
Use of Incorrect Control/Treatment Settings 2 2
Connection Problem 2 2
Power Problem 2 2
Pacing Asynchronously 2 2
Pacing Inadequately 2 2
Key or Button Unresponsive/not Working 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 445 445
Insufficient Information 55 55
Cardiac Arrest 51 51
Unspecified Heart Problem 33 33
No Patient Involvement 31 31
Bradycardia 6 6
No Consequences Or Impact To Patient 6 6
No Information 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
Ventricular Fibrillation 2 2
Shock from Patient Lead(s) 2 2
Dyspnea 1 1
Chest Pain 1 1
Arrhythmia 1 1
Skin Irritation 1 1
Swelling 1 1
Burn, Thermal 1 1
Heart Block 1 1
Asystole 1 1
Twitching 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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