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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
CARDIO MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
FIAB S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
FULL POWER AED
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS NORTH AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES, LTD, A PHILIPS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 480 480
2015 86 86
2016 58 58
2017 49 49
2018 28 28
2019 34 34
2020 19 19
2021 22 22
2022 80 80
2023 263 263
2024 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Device Inoperable 162 162
No Pacing 147 147
Failure to Deliver Shock/Stimulation 77 77
Device Displays Incorrect Message 73 73
Device Operates Differently Than Expected 65 65
Failure to Discharge 47 47
Connection Problem 44 44
Failure to Charge 43 43
Pacing Problem 39 39
Failure of Device to Self-Test 39 39
Break 37 37
Failure to Power Up 33 33
Unable to Obtain Readings 32 32
Failure to Deliver Energy 32 32
Battery Problem 31 31
Appropriate Term/Code Not Available 27 27
Failure To Run On AC/DC 25 25
Defibrillation/Stimulation Problem 23 23
Device Sensing Problem 22 22
Inappropriate/Inadequate Shock/Stimulation 20 20
Loose or Intermittent Connection 18 18
Insufficient Information 18 18
Charging Problem 14 14
Output Problem 11 11
No Display/Image 10 10
Loss of Power 10 10
Mechanical Problem 9 9
Electrical /Electronic Property Problem 9 9
Material Fragmentation 9 9
Therapeutic or Diagnostic Output Failure 9 9
Low Battery 8 8
Fitting Problem 8 8
Failure to Sense 7 7
Energy Output Problem 6 6
Display or Visual Feedback Problem 6 6
Circuit Failure 6 6
Defective Device 6 6
Defective Component 5 5
Communication or Transmission Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Noise, Audible 5 5
Intermittent Continuity 5 5
No Device Output 5 5
Overheating of Device 5 5
Use of Device Problem 5 5
Low impedance 4 4
Failure to Analyze Signal 4 4
Failure to Read Input Signal 4 4
Detachment Of Device Component 4 4
Grounding Malfunction 4 4
Incomplete or Inadequate Connection 4 4
Computer Operating System Problem 4 4
Detachment of Device or Device Component 4 4
Arcing 3 3
Power Problem 3 3
Protective Measures Problem 3 3
Device Handling Problem 3 3
Computer Software Problem 3 3
Premature Discharge of Battery 3 3
Crack 3 3
Use of Incorrect Control/Treatment Settings 2 2
Signal Artifact/Noise 2 2
High impedance 2 2
Image Display Error/Artifact 2 2
Fracture 2 2
Failure to Select Signal 2 2
Self-Activation or Keying 2 2
Improper or Incorrect Procedure or Method 2 2
Device Stops Intermittently 2 2
Pacing Asynchronously 2 2
Pacing Inadequately 2 2
Failure to Shut Off 2 2
Device Operational Issue 2 2
Mechanical Jam 2 2
Naturally Worn 2 2
Incorrect Or Inadequate Test Results 2 2
Split 1 1
Difficult or Delayed Activation 1 1
Component Missing 1 1
Sparking 1 1
Application Program Problem 1 1
Delivery System Failure 1 1
Device Contamination with Chemical or Other Material 1 1
Inappropriate or Unexpected Reset 1 1
Material Integrity Problem 1 1
Scratched Material 1 1
Output below Specifications 1 1
Activation Failure 1 1
Intermittent Communication Failure 1 1
Key or Button Unresponsive/not Working 1 1
Component Misassembled 1 1
Unintended Electrical Shock 1 1
Pacing Intermittently 1 1
Peeled/Delaminated 1 1
Failure to Run on Battery 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Output above Specifications 1 1
Misconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 545 545
No Clinical Signs, Symptoms or Conditions 340 340
No Known Impact Or Consequence To Patient 115 115
Insufficient Information 47 47
Cardiac Arrest 43 43
No Consequences Or Impact To Patient 33 33
Death 26 26
Unspecified Heart Problem 24 24
No Information 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Sudden Cardiac Death 4 4
Burn, Thermal 3 3
Ventricular Fibrillation 3 3
Bradycardia 3 3
Chest Pain 2 2
Hemorrhage/Bleeding 2 2
Dyspnea 2 2
Shock from Patient Lead(s) 2 2
Asystole 1 1
Heart Block 1 1
Erythema 1 1
Twitching 1 1
Unknown (for use when the patient's condition is not known) 1 1
Rash 1 1
Skin Irritation 1 1
Swelling 1 1
Burn(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardio Medical Products II Jul-08-2013
2 ConMed Corporation I Dec-04-2014
3 ConMed Corporation II Jan-12-2012
4 Physio Control, Inc. II Nov-16-2011
5 Physio Control, Inc. II Aug-28-2010
6 Physio Control, Inc. II Apr-07-2009
7 Remote Diagnostic Technologies Ltd. II Jun-12-2023
8 Remote Diagnostic Technologies Ltd. II Apr-04-2022
9 Remote Diagnostic Technologies Ltd. II Dec-11-2020
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