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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 149 149

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 194 194
Failure to Deliver Shock/Stimulation 80 80
Pacing Problem 54 54
Unable to Obtain Readings 45 45
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 13 13
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
Failure to Power Up 8 8
Mechanical Problem 7 7
Circuit Failure 6 6
No Device Output 6 6
Incomplete or Inadequate Connection 6 6
Detachment of Device or Device Component 6 6
Device Handling Problem 6 6
Fitting Problem 5 5
Display or Visual Feedback Problem 5 5
Battery Problem 5 5
Erratic or Intermittent Display 4 4
Intermittent Continuity 4 4
Grounding Malfunction 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Failure to Analyze Signal 4 4
Incorrect Measurement 4 4
Use of Device Problem 4 4
Failure to Discharge 4 4
Communication or Transmission Problem 4 4
Defective Component 3 3
Defibrillation/Stimulation Problem 3 3
No Display/Image 3 3
Computer Software Problem 3 3
Fracture 3 3
Protective Measures Problem 3 3
Material Integrity Problem 2 2
Charging Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Misconnection 2 2
Wireless Communication Problem 2 2
Pacing Inadequately 2 2
Mechanical Jam 2 2
Pacing Asynchronously 2 2
Peeled/Delaminated 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 430 430
Insufficient Information 55 55
Cardiac Arrest 50 50
No Patient Involvement 31 31
Unspecified Heart Problem 29 29
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 Physio-Control, Inc. II Oct-22-2024
2 Remote Diagnostic Technologies Ltd. II Jun-06-2024
3 Remote Diagnostic Technologies Ltd. II Jun-12-2023
4 Remote Diagnostic Technologies Ltd. II Apr-04-2022
5 Remote Diagnostic Technologies Ltd. II Dec-11-2020
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