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TPLC
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show TPLC since
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Device
dc-defibrillator, low-energy, (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
149
149
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Pacing
194
194
Failure to Deliver Shock/Stimulation
80
80
Pacing Problem
54
54
Unable to Obtain Readings
45
45
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
13
13
Failure to Charge
11
11
Device Sensing Problem
10
10
Output Problem
10
10
Failure to Deliver Energy
9
9
Therapeutic or Diagnostic Output Failure
9
9
Electrical /Electronic Property Problem
9
9
Failure to Power Up
8
8
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
Fitting Problem
5
5
Display or Visual Feedback Problem
5
5
Battery Problem
5
5
Erratic or Intermittent Display
4
4
Intermittent Continuity
4
4
Grounding Malfunction
4
4
Inappropriate/Inadequate Shock/Stimulation
4
4
Failure to Analyze Signal
4
4
Incorrect Measurement
4
4
Use of Device Problem
4
4
Failure to Discharge
4
4
Communication or Transmission Problem
4
4
Defective Component
3
3
Defibrillation/Stimulation Problem
3
3
No Display/Image
3
3
Computer Software Problem
3
3
Fracture
3
3
Protective Measures Problem
3
3
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
Mechanical Jam
2
2
Pacing Asynchronously
2
2
Peeled/Delaminated
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
430
430
Insufficient Information
55
55
Cardiac Arrest
50
50
No Patient Involvement
31
31
Unspecified Heart Problem
29
29
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
Swelling
1
1
Twitching
1
1
Chest Pain
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.
II
Jun-06-2024
3
Remote Diagnostic Technologies Ltd.
II
Jun-12-2023
4
Remote Diagnostic Technologies Ltd.
II
Apr-04-2022
5
Remote Diagnostic Technologies Ltd.
II
Dec-11-2020
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