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	66	66

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Pacing	151	151
Failure to Deliver Shock/Stimulation	74	74
Pacing Problem	38	38
Failure of Device to Self-Test	33	33
Unable to Obtain Readings	30	30
Appropriate Term/Code Not Available	27	27
Loose or Intermittent Connection	16	16
Insufficient Information	16	16
Therapeutic or Diagnostic Output Failure	9	9
Device Sensing Problem	9	9
Failure to Charge	9	9
Failure to Deliver Energy	9	9
Electrical /Electronic Property Problem	8	8
Output Problem	8	8
Mechanical Problem	7	7
Failure to Power Up	6	6
Circuit Failure	6	6
Break	5	5
Display or Visual Feedback Problem	5	5
Incomplete or Inadequate Connection	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
Defective Component	3	3
Fitting Problem	3	3
Defibrillation/Stimulation Problem	3	3
Inappropriate/Inadequate Shock/Stimulation	3	3
Detachment of Device or Device Component	3	3
Protective Measures Problem	3	3
Computer Software Problem	3	3
Failure to Discharge	3	3
Device Handling Problem	3	3
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
Peeled/Delaminated	2	2
Pacing Asynchronously	2	2
Pacing Inadequately	2	2
Connection Problem	2	2
Mechanical Jam	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Low impedance	2	2
Battery Problem	2	2
Charging Problem	1	1
Computer Operating System Problem	1	1
Defective Device	1	1
Application Program Problem	1	1
Failure to Read Input Signal	1	1
Failure to Select Signal	1	1
No Audible Prompt/Feedback	1	1
Improper or Incorrect Procedure or Method	1	1
Output below Specifications	1	1
Power Problem	1	1
Failure to Shut Off	1	1
Material Integrity Problem	1	1
Activation Failure	1	1
Component Misassembled	1	1
Unintended Electrical Shock	1	1
Pacing Intermittently	1	1
Misconnection	1	1
Output above Specifications	1	1
Incorrect Measurement	1	1
Failure to Run on Battery	1	1
Loss of Power	1	1
Product Quality Problem	1	1
Failure to Convert Rhythm	1	1
Failure to Sense	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Fragmentation	1	1
Fire	1	1
Erratic or Intermittent Display	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	347	347
Insufficient Information	47	47
Cardiac Arrest	41	41
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