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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)
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
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES, LTD, A PHILIPS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
  1.  K200849  Tempus LS - Manual

MDR Year MDR Reports MDR Events
2019 34 34
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 84 84
Pacing Problem 55 55
Unable to Obtain Readings 48 48
Failure of Device to Self-Test 39 39
Appropriate Term/Code Not Available 27 27
Insufficient Information 22 22
Loose or Intermittent Connection 17 17
Break 15 15
Failure to Charge 11 11
Device Sensing Problem 10 10
Output Problem 10 10
Failure to Deliver Energy 9 9
Electrical /Electronic Property Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Failure to Power Up 9 9
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
Battery Problem 6 6
Fitting Problem 5 5
Failure to Discharge 5 5
Display or Visual Feedback Problem 5 5
Intermittent Continuity 4 4
Erratic or Intermittent Display 4 4
Grounding Malfunction 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Defibrillation/Stimulation Problem 4 4
Failure to Analyze Signal 4 4
Incorrect Measurement 4 4
Use of Device Problem 4 4
Communication or Transmission Problem 4 4
Material Fragmentation 3 3
Defective Component 3 3
Computer Software Problem 3 3
No Display/Image 3 3
Fracture 3 3
Protective Measures Problem 3 3
Key or Button Unresponsive/not Working 2 2
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
Pacing Asynchronously 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 31 31
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 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
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