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

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Pacing	211	211
Failure to Deliver Shock/Stimulation	77	77
Unable to Obtain Readings	58	58
Pacing Problem	58	58
Failure of Device to Self-Test	42	43
Appropriate Device Problem Term/Code Not Available	27	27
Insufficient Device Problem Information	22	22
Break	19	19
Loose or Intermittent Connection	18	18
Failure to Charge	16	16
Device Sensing Problem	12	12
Electrical /Electronic Property Problem	11	11
Battery Problem	10	10
Mechanical Problem	9	9
Output Problem	9	9
Therapeutic or Diagnostic Output Failure	8	8
Failure to Power Up	8	8
Defibrillation/Stimulation Problem	8	8
Incomplete or Inadequate Connection	8	8
Crack	8	8
Display or Visual Feedback Problem	7	8
Inappropriate/Inadequate Shock/Stimulation	6	6
Device Handling Problem	6	6
Circuit Failure	6	6
Detachment of Device or Device Component	6	6
Fitting Problem	6	6
Failure to Discharge	6	6
No Device Output	6	6
Fracture	5	5
Failure to Deliver Energy	5	5
Incorrect Measurement	5	5
Erratic or Intermittent Display	5	5
Protective Measures Problem	5	5
Communication or Transmission Problem	4	4
Failure to Analyze Signal	4	4
Key or Button Unresponsive/not Working	4	4
Grounding Malfunction	4	4
No Display/Image	4	4
Use of Device Problem	4	4
Material Fragmentation	3	3
Material Integrity Problem	3	3
Computer Software Problem	3	3
Operating System Becomes Nonfunctional	3	3
Wireless Communication Problem	3	3
Power Problem	3	3
Pacing Asynchronously	2	2
Activation Failure	2	2
Image Display Error/Artifact	2	2
Pacing Inadequately	2	2
No Audible Prompt/Feedback	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	528	530
Cardiac Arrest	61	64
Insufficient Information	58	58
Unspecified Heart Problem	37	37
Bradycardia	8	8
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Asystole	2	2
Chest Pain	2	2
Twitching	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Heart Block	1	1
Shock from Patient Lead(s)	1	1
Arrhythmia	1	1
Dyspnea	1	1
Death	1	1
Mydriasis	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