TPLC - Total Product Life Cycle

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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
REMOTE DIAGNOSTIC TECHNOLOGIES, LTD. A PHILIPS COMPANY
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Pacing	211	211
Failure to Deliver Shock/Stimulation	94	95
Unable to Obtain Readings	60	62
Pacing Problem	59	59
Failure of Device to Self-Test	42	43
Appropriate Term/Code Not Available	27	27
Insufficient Information	22	22
Break	19	19
Loose or Intermittent Connection	18	18
Failure to Charge	16	16
Device Sensing Problem	14	15
Electrical /Electronic Property Problem	11	11
Output Problem	10	10
Battery Problem	10	10
Mechanical Problem	9	9
Crack	9	9
Defibrillation/Stimulation Problem	8	8
Incomplete or Inadequate Connection	8	8
Failure to Power Up	8	8
Therapeutic or Diagnostic Output Failure	8	8
Failure to Discharge	7	7
Display or Visual Feedback Problem	7	8
Circuit Failure	6	6
Fitting Problem	6	6
Detachment of Device or Device Component	6	6
No Device Output	6	6
Device Handling Problem	6	6
Fracture	5	5
Erratic or Intermittent Display	5	5
Protective Measures Problem	5	5
Incorrect Measurement	5	5
Failure to Deliver Energy	5	5
Failure to Analyze Signal	4	4
Key or Button Unresponsive/not Working	4	4
Use of Device Problem	4	4
Grounding Malfunction	4	4
Communication or Transmission Problem	4	4
No Display/Image	4	4
Inappropriate/Inadequate Shock/Stimulation	4	4
Wireless Communication Problem	3	3
Material Fragmentation	3	3
Power Problem	3	3
Operating System Becomes Nonfunctional	3	3
Computer Software Problem	3	3
Material Integrity Problem	2	2
No Audible Alarm	2	2
Pacing Inadequately	2	2
Image Display Error/Artifact	2	2
Charging Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	524	526
Cardiac Arrest	61	64
Insufficient Information	59	59
Unspecified Heart Problem	37	37
No Patient Involvement	9	9
Bradycardia	8	8
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
Chest Pain	2	2
Asystole	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	2
Swelling	1	1
Twitching	1	1
Dyspnea	1	1
Hemorrhage/Bleeding	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