Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
REMOTE DIAGNOSTIC TECHNOLOGIES, LTD, A PHILIPS COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 19 19
2021 22 22
2022 80 80
2023 264 264
2024 160 160
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 206 206
Failure to Deliver Shock/Stimulation 76 76
Pacing Problem 55 55
Unable to Obtain Readings 48 48
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 15 15
Failure to Charge 10 10
Device Sensing Problem 10 10
Output Problem 10 10
Electrical /Electronic Property Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8
Failure to Power Up 8 8
Mechanical Problem 7 7
Incomplete or Inadequate Connection 6 6
No Device Output 6 6
Battery Problem 6 6
Circuit Failure 6 6
Detachment of Device or Device Component 6 6
Device Handling Problem 6 6
Display or Visual Feedback Problem 5 5
Failure to Discharge 5 5
Fitting Problem 5 5
Failure to Deliver Energy 5 5
Communication or Transmission Problem 4 4
Failure to Analyze Signal 4 4
Erratic or Intermittent Display 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Defibrillation/Stimulation Problem 4 4
Incorrect Measurement 4 4
No Display/Image 3 3
Protective Measures Problem 3 3
Fracture 3 3
Computer Software Problem 3 3
Material Fragmentation 3 3
Use of Device Problem 3 3
Mechanical Jam 2 2
Grounding Malfunction 2 2
Intermittent Continuity 2 2
Power Problem 2 2
Activation Failure 2 2
Pacing Asynchronously 2 2
Misconnection 2 2
Use of Incorrect Control/Treatment Settings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Key or Button Unresponsive/not Working 2 2
Material Integrity Problem 2 2
Wireless Communication Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 451 451
Insufficient Information 57 57
Cardiac Arrest 51 51
Unspecified Heart Problem 33 33
No Patient Involvement 9 9
Bradycardia 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Information 3 3
No Consequences Or Impact To Patient 3 3
Death 2 2
Arrhythmia 1 1
Skin Irritation 1 1
Shock from Patient Lead(s) 1 1
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 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 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
-
-