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

MDR Year MDR Reports MDR Events
2020 19 19
2021 22 22
2022 80 80
2023 264 264
2024 160 160
2025 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
No Pacing 207 207
Failure to Deliver Shock/Stimulation 80 80
Pacing Problem 56 56
Unable to Obtain Readings 52 52
Failure of Device to Self-Test 39 39
Appropriate Term/Code Not Available 27 27
Insufficient Information 22 22
Loose or Intermittent Connection 18 18
Break 16 16
Failure to Charge 10 10
Electrical /Electronic Property Problem 10 10
Output Problem 10 10
Device Sensing Problem 10 10
Mechanical Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Failure to Power Up 8 8
Circuit Failure 6 6
No Device Output 6 6
Failure to Discharge 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
Failure to Deliver Energy 5 5
Fitting Problem 5 5
Display or Visual Feedback Problem 5 5
Defibrillation/Stimulation Problem 5 5
Failure to Analyze Signal 4 4
Communication or Transmission Problem 4 4
Crack 4 4
Protective Measures Problem 4 4
Fracture 4 4
Erratic or Intermittent Display 4 4
Inappropriate/Inadequate Shock/Stimulation 4 4
Incorrect Measurement 4 4
Computer Software Problem 3 3
Use of Device Problem 3 3
Material Fragmentation 3 3
No Display/Image 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Misconnection 2 2
Key or Button Unresponsive/not Working 2 2
Mechanical Jam 2 2
Pacing Asynchronously 2 2
Material Integrity Problem 2 2
Activation Failure 2 2
Wireless Communication Problem 2 2
Pacing Inadequately 2 2
High impedance 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 466 466
Insufficient Information 57 57
Cardiac Arrest 53 53
Unspecified Heart Problem 35 35
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
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