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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 127 127

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 184 184
Failure to Deliver Shock/Stimulation 79 79
Pacing Problem 53 53
Unable to Obtain Readings 43 43
Failure of Device to Self-Test 37 37
Appropriate Term/Code Not Available 27 27
Insufficient Information 22 22
Loose or Intermittent Connection 16 16
Break 12 12
Failure to Charge 11 11
Device Sensing Problem 10 10
Output Problem 10 10
Failure to Deliver Energy 9 9
Therapeutic or Diagnostic Output Failure 9 9
Electrical /Electronic Property Problem 9 9
Mechanical Problem 7 7
Failure to Power Up 7 7
Circuit Failure 6 6
Detachment of Device or Device Component 6 6
Incomplete or Inadequate Connection 6 6
Fitting Problem 5 5
No Device Output 5 5
Display or Visual Feedback Problem 5 5
Incorrect Measurement 4 4
Battery Problem 4 4
Communication or Transmission Problem 4 4
Failure to Analyze Signal 4 4
Grounding Malfunction 4 4
Intermittent Continuity 4 4
Erratic or Intermittent Display 4 4
Use of Device Problem 4 4
Fracture 3 3
Protective Measures Problem 3 3
Computer Software Problem 3 3
Device Handling Problem 3 3
Defibrillation/Stimulation Problem 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Failure to Discharge 3 3
Defective Component 3 3
No Display/Image 3 3
Low impedance 2 2
Power Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Connection Problem 2 2
Pacing Asynchronously 2 2
Material Integrity Problem 2 2
Peeled/Delaminated 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Mechanical Jam 2 2
Crack 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 409 409
Insufficient Information 55 55
Cardiac Arrest 49 49
No Patient Involvement 31 31
Unspecified Heart Problem 26 26
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
Swelling 1 1
Twitching 1 1
Chest Pain 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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