TPLC - Total Product Life Cycle

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Device	over-the-counter automated external defibrillator
Regulation Description	Automated external defibrillator system.
Definition	Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.
Product Code	NSA
Regulation Number	870.5310
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
6	5	4	4	2	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure of Device to Self-Test	491	493
Failure to Power Up	175	178
No Audible Prompt/Feedback	54	55
Inaudible or Unclear Audible Prompt/Feedback	46	46
Failure to Run on Battery	44	44
Inappropriate Audible Prompt/Feedback	32	32
Material Split, Cut or Torn	32	32
Electrical /Electronic Property Problem	28	28
Key or Button Unresponsive/not Working	25	25
Failure to Deliver Shock/Stimulation	23	24
Battery Problem	18	18
Audible Prompt/Feedback Problem	17	17
Premature Discharge of Battery	16	16
Device Alarm System	16	16
No Visual Prompts/Feedback	11	12
Unexpected Shutdown	8	8
Device Sensing Problem	8	8
Material Integrity Problem	8	8
Failure to Analyze Signal	6	6
Failure to Sense	6	6
Connection Problem	5	5
Display or Visual Feedback Problem	4	4
Failure to Deliver Energy	3	3
Defibrillation/Stimulation Problem	3	3
Noise, Audible	3	3
Mechanical Problem	3	3
Smoking	2	2
Incorrect Interpretation of Signal	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Handling Problem	2	2
Power Problem	1	1
Difficult or Delayed Activation	1	1
No Apparent Adverse Event	1	1
Alarm Not Visible	1	1
Sparking	1	1
Moisture Damage	1	1
No Display/Image	1	1
Program or Algorithm Execution Problem	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Intermittent Loss of Power	1	1
Device Damaged Prior to Receipt by User	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1052	1058
Cardiac Arrest	26	26
Insufficient Information	7	7
No Patient Involvement	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Ventricular Fibrillation	1	1