TPLC - Total Product Life Cycle

• 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	263	263
2024	60	60

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Pacing	146	146
Failure to Deliver Shock/Stimulation	74	74
Pacing Problem	37	37
Failure of Device to Self-Test	33	33
Unable to Obtain Readings	30	30
Appropriate Term/Code Not Available	27	27
Insufficient Information	16	16
Loose or Intermittent Connection	16	16
Failure to Charge	9	9
Failure to Deliver Energy	9	9
Therapeutic or Diagnostic Output Failure	9	9
Device Sensing Problem	9	9
Output Problem	8	8
Electrical /Electronic Property Problem	7	7
Mechanical Problem	7	7
Circuit Failure	6	6
Break	5	5
Display or Visual Feedback Problem	5	5
Failure to Power Up	5	5
Grounding Malfunction	4	4
Intermittent Continuity	4	4
Failure to Analyze Signal	4	4
Use of Device Problem	4	4
No Device Output	4	4
Communication or Transmission Problem	4	4
Incomplete or Inadequate Connection	4	4
Detachment of Device or Device Component	3	3
Defective Component	3	3
Protective Measures Problem	3	3
Device Handling Problem	3	3
Computer Software Problem	3	3
Failure to Discharge	3	3
Defibrillation/Stimulation Problem	3	3
Inappropriate/Inadequate Shock/Stimulation	3	3
Pacing Asynchronously	2	2
Pacing Inadequately	2	2
No Display/Image	2	2
Use of Incorrect Control/Treatment Settings	2	2
High impedance	2	2
Image Display Error/Artifact	2	2
Fracture	2	2
Mechanical Jam	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Battery Problem	2	2
Connection Problem	2	2
Low impedance	2	2
Fitting Problem	2	2
No Audible Prompt/Feedback	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Convert Rhythm	1	1
Failure to Sense	1	1
Computer Operating System Problem	1	1
Charging Problem	1	1
Defective Device	1	1
Application Program Problem	1	1
Output below Specifications	1	1
Failure to Shut Off	1	1
Material Integrity Problem	1	1
Power Problem	1	1
Activation Failure	1	1
Component Misassembled	1	1
Unintended Electrical Shock	1	1
Material Fragmentation	1	1
Fire	1	1
Erratic or Intermittent Display	1	1
Pacing Intermittently	1	1
Peeled/Delaminated	1	1
Failure to Run on Battery	1	1
Loss of Power	1	1
Misconnection	1	1
Output above Specifications	1	1
Incorrect Measurement	1	1
Failure to Read Input Signal	1	1
Failure to Select Signal	1	1
Product Quality Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Intermittent Communication Failure	1	1
Key or Button Unresponsive/not Working	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	340	340
Insufficient Information	47	47
Cardiac Arrest	39	39
No Patient Involvement	31	31
Unspecified Heart Problem	24	24
No Information	6	6
No Consequences Or Impact To Patient	6	6
Death	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
No Known Impact Or Consequence To Patient	3	3
Bradycardia	3	3
Shock from Patient Lead(s)	2	2
Ventricular Fibrillation	2	2
Twitching	1	1
Chest Pain	1	1
Dyspnea	1	1
Skin Irritation	1	1
Swelling	1	1
Burn, Thermal	1	1
Asystole	1	1
Heart Block	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Remote Diagnostic Technologies Ltd.	II	Jun-12-2023
2	Remote Diagnostic Technologies Ltd.	II	Apr-04-2022
3	Remote Diagnostic Technologies Ltd.	II	Dec-11-2020