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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)
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 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 190 190
Failure to Deliver Shock/Stimulation 80 80
Pacing Problem 54 54
Unable to Obtain Readings 44 44
Failure of Device to Self-Test 38 38
Appropriate Term/Code Not Available 27 27
Insufficient Information 22 22
Loose or Intermittent Connection 17 17
Break 12 12
Failure to Charge 11 11
Output Problem 10 10
Device Sensing Problem 10 10
Electrical /Electronic Property Problem 9 9
Failure to Deliver Energy 9 9
Therapeutic or Diagnostic Output Failure 9 9
Failure to Power Up 8 8
Mechanical Problem 7 7
No Device Output 6 6
Circuit Failure 6 6
Detachment of Device or Device Component 6 6
Device Handling Problem 6 6
Incomplete or Inadequate Connection 6 6
Battery Problem 5 5
Fitting Problem 5 5
Display or Visual Feedback Problem 5 5
Incorrect Measurement 4 4
Grounding Malfunction 4 4
Intermittent Continuity 4 4
Erratic or Intermittent Display 4 4
Failure to Analyze Signal 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Use of Device Problem 4 4
Communication or Transmission Problem 4 4
Protective Measures Problem 3 3
Defibrillation/Stimulation Problem 3 3
Defective Component 3 3
No Display/Image 3 3
Failure to Discharge 3 3
Fracture 3 3
Computer Software Problem 3 3
Use of Incorrect Control/Treatment Settings 2 2
Crack 2 2
High impedance 2 2
Image Display Error/Artifact 2 2
Misconnection 2 2
Peeled/Delaminated 2 2
Pacing Asynchronously 2 2
Pacing Inadequately 2 2
Low impedance 2 2
Power Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 423 423
Insufficient Information 55 55
Cardiac Arrest 50 50
No Patient Involvement 31 31
Unspecified Heart Problem 28 28
No Information 6 6
Bradycardia 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
Arrhythmia 1 1
Skin Irritation 1 1
Burn, Thermal 1 1
Chest Pain 1 1
Swelling 1 1
Twitching 1 1
Dyspnea 1 1
Asystole 1 1
Heart Block 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Remote Diagnostic Technologies Ltd. II Jun-06-2024
2 Remote Diagnostic Technologies Ltd. II Jun-12-2023
3 Remote Diagnostic Technologies Ltd. II Apr-04-2022
4 Remote Diagnostic Technologies Ltd. II Dec-11-2020
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