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TPLC
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Device
dc-defibrillator, low-energy, (including paddles)
Regulation Description
DC-defibrillator (including paddles).
Product Code
LDD
Regulation Number
870.5300
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
160
160
2025
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Pacing
203
203
Failure to Deliver Shock/Stimulation
82
82
Pacing Problem
54
54
Unable to Obtain Readings
47
47
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
14
14
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
8
8
Mechanical Problem
7
7
Incomplete or Inadequate Connection
6
6
Circuit Failure
6
6
Device Handling Problem
6
6
No Device Output
6
6
Battery Problem
6
6
Detachment of Device or Device Component
6
6
Fitting Problem
5
5
Display or Visual Feedback Problem
5
5
Failure to Discharge
5
5
Communication or Transmission Problem
4
4
Failure to Analyze Signal
4
4
Inappropriate/Inadequate Shock/Stimulation
4
4
Incorrect Measurement
4
4
Grounding Malfunction
4
4
Use of Device Problem
4
4
Defibrillation/Stimulation Problem
4
4
Intermittent Continuity
4
4
Erratic or Intermittent Display
4
4
Material Fragmentation
3
3
No Display/Image
3
3
Defective Component
3
3
Computer Software Problem
3
3
Fracture
3
3
Protective Measures Problem
3
3
Crack
2
2
Image Display Error/Artifact
2
2
High impedance
2
2
Use of Incorrect Control/Treatment Settings
2
2
Connection Problem
2
2
Power Problem
2
2
Pacing Asynchronously
2
2
Pacing Inadequately
2
2
Key or Button Unresponsive/not Working
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
445
445
Insufficient Information
55
55
Cardiac Arrest
51
51
Unspecified Heart Problem
33
33
No Patient Involvement
31
31
Bradycardia
6
6
No Consequences Or Impact To Patient
6
6
No Information
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
Ventricular Fibrillation
2
2
Shock from Patient Lead(s)
2
2
Dyspnea
1
1
Chest Pain
1
1
Arrhythmia
1
1
Skin Irritation
1
1
Swelling
1
1
Burn, Thermal
1
1
Heart Block
1
1
Asystole
1
1
Twitching
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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